Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior, 20882-20897 [2024-06037]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Proposed Rules]
[Pages 20882-20897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2023-N-3902]
RIN 0910-AI84


Banned Devices; Proposal To Ban Electrical Stimulation Devices 
for Self-Injurious or Aggressive Behavior

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to ban electrical stimulation devices (ESDs) intended for 
self-injurious behavior (SIB) or aggressive behavior (AB). FDA has 
determined these devices present an unreasonable and substantial risk 
of illness or injury that cannot be corrected or eliminated by 
labeling. This proposal follows a court decision vacating a prior ban 
and amendment to the Federal Food, Drug, and Cosmetic Act clarifying 
our authority to ban a device for one or more intended uses. This 
action, if finalized, will mean ESDs for SIB and AB are adulterated and 
not legally marketed.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by May 28, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 28, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-3902 for ``Banned Devices; Proposal to Ban Electrical 
Stimulation Devices for Self-Injurious or Aggressive Behavior.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you

[[Page 20883]]

must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents, the 
plain language summary of the proposed rule of not more than 100 words 
as required by the ``Providing Accountability Through Transparency 
Act,'' or the electronic and written/paper comments received, go to 
https://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
    D. History of the Rulemaking
IV. Legal Authority
V. Evaluation and Discussion of Data and Information
    A. Risks of ESDs for SIB or AB
    B. Effects of ESDs for SIB or AB
    C. State of the Art for Treating SIB or AB
    D. Labeling and Correcting or Eliminating Substantial and 
Unreasonable Risks
VI. Description of the Proposed Rule
    A. Applicability (Proposed Sec.  895.105)
    B. Proposed Conforming Amendment (Sec.  882.5235)
VII. Proposed Effective and Compliance Dates
VIII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits, Costs, and Transfers
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to ban ESDs intended for self-injurious behavior 
(SIB) or aggressive behavior (AB) pursuant to the Agency's authority 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) after 
determining that the devices present an unreasonable and substantial 
risk of illness or injury that cannot be corrected or eliminated by 
labeling. FDA previously issued a final rule in 2020 banning these 
devices (2020 Final Rule) (85 FR 13312, March 6, 2020), which was 
vacated by the U.S. Court of Appeals for the District of Columbia 
Circuit (D.C. Circuit) on July 6, 2021. The D.C. Circuit opined that 
FDA's authority to ban devices intended for human use under the FD&C 
Act, as it existed at the time, did not permit FDA to ban a device for 
some (but not all) of its intended uses. Following the D.C. Circuit's 
decision, Congress amended the FD&C Act to expressly state that FDA's 
authority to ban a device includes the authority to ban some intended 
uses of a device, even if the Agency does not seek to ban it for all 
intended uses. The amendment to the FD&C Act thereby authorizes FDA to 
issue a ban that applies to specific intended uses, such as the 
previous ban on ESDs for self-injurious and aggressive behavior. This 
proposed rule, if finalized, would reestablish the ban now that it is 
clear that FDA has the authority to do so.
    ESDs are aversive conditioning devices that apply a noxious 
electrical stimulus (a shock) to a person's skin to condition behavior 
to reduce or cease SIB and AB. SIB and AB frequently manifest in the 
same individual, and people with intellectual or developmental 
disabilities exhibit these behaviors at disproportionately high rates. 
Notably, some people with intellectual or developmental disabilities 
who exhibit SIB and AB have difficulty communicating and cannot make 
their own treatment decisions because of such disabilities, meaning 
they are part of a vulnerable population.
    In issuing the 2020 Final Rule, FDA determined that the medical 
literature shows that ESDs for SIB or AB pose a number of psychological 
harms including depression, post-traumatic stress disorder (PTSD), 
anxiety, fear, panic, substitution of other negative behaviors, 
worsening of underlying symptoms, and learned helplessness (becoming 
unable or unwilling to respond in any way to the ESD); and the devices 
present the physical risks of pain, skin burns, and tissue damage. We 
also found that other sources, such as experts in the field, State 
agencies that regulate ESD use, and records from the only facility that 
has recently manufactured and is currently using ESDs for SIB or AB, 
indicate that ESDs pose additional risks such as suicidality, chronic 
stress, acute stress disorder, neuropathy, withdrawal, nightmares, 
flashbacks of panic and rage, hypervigilance, insensitivity to fatigue 
or pain, changes in sleep patterns, loss of interest, difficulty 
concentrating, and injuries from falling. We also determined that 
state-of-the-art treatments for this patient population have evolved 
away from ones that include ESD use and toward various positive 
behavioral treatments, sometimes combined with pharmacological 
treatments. Although the available data and information suggest that 
some individuals subject to ESDs exhibit an immediate reduction or 
cessation of the targeted behavior, the available evidence has not 
established a durable long-term conditioning effect or an overall 
favorable benefit-risk profile for ESDs for SIB and AB.
    For this proposed rule, FDA has determined that there have been no 
material changes regarding these topics in the available literature 
that impact our findings and assessments in the 2020 Final Rule. 
Accordingly, FDA has determined on the basis of all available data and 
information that ESDs for SIB or AB present an unreasonable and 
substantial risk of illness or injury and that such risk cannot be 
corrected or eliminated by labeling or by a change in labeling. FDA is 
issuing this proposed rule to give notice of FDA's determination and 
give interested persons an opportunity to comment on the determination 
and FDA's proposal to ban ESDs for SIB and AB. All references to 
section numbers are references to section numbers in this proposed rule 
unless otherwise specified.

B. Summary of the Major Provisions of the Proposed Rule

    We are proposing to amend part 895 (21 CFR part 895) to designate 
ESDs for SIB or AB as banned devices. If this proposed rule is 
finalized as proposed, the ban would include only aversive conditioning 
devices intended to apply a noxious electrical stimulus to a person's 
skin to reduce or cease aggressive or self-injurious behavior. The 
proposed ban would apply to devices already in commercial

[[Page 20884]]

distribution and devices already in use by the ultimate (end) user, as 
well as devices to be sold or commercially distributed in the future. A 
banned device is an adulterated device, subject to enforcement action. 
Additionally, a device that is banned for one or more intended uses is 
not legally marketed within the meaning of section 1006 of the FD&C Act 
(21 U.S.C. 396) when intended for such use or uses. The ban would not, 
however, prevent further study of such devices pursuant to an 
investigational device exemption if the requirements for such an 
exemption are met. We also are proposing conforming edits to 21 CFR 
part 882 to clarify that ESDs are banned when used to reduce or cease 
SIB or AB.

C. Legal Authority

    We are proposing to issue this rule pursuant to FDA's authority to 
ban devices intended for human use, as recently amended by Congress. We 
also are proposing to issue this rule under the authority to issue 
regulations for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

    This proposed rule, if finalized, would reestablish the ban of ESDs 
for SIB or AB. FDA has determined that these devices present an 
unreasonable and substantial risk of illness or injury that cannot be 
corrected or eliminated by labeling or a change in labeling. The 
proposed rule, if finalized, would apply to both new devices and 
devices already in distribution and use. Unquantified benefits would 
include reduction in physical and psychological adverse effects from 
using ESDs on individuals, as well as benefits to society in terms of 
protecting vulnerable populations. We quantify costs for the case in 
which the affected individuals might move to another facility and costs 
to the affected entities, who use the device on such individuals, to 
read and understand the rule. We estimate that the annualized costs 
over 10 years would range from $0.00 million to $9.17 million with a 
primary estimate of $4.59 million at both a 7 percent and a 3 percent 
discount rate.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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        Abbreviation/ acronym                    What it means
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AB..................................  Aggressive Behavior.
ABA.................................  Applied Behavior Analysis.
ABAI................................  Association for Behavior Analysis
                                       International.
AE..................................  Adverse Event.
DBT.................................  Dialectical Behavioral Therapy.
EA..................................  Environmental Assessment.
ESD.................................  Electrical Stimulation Device.
FA..................................  Analogue Functional Analysis.
FDORA...............................  Food and Drug Omnibus Reform Act
                                       of 2022.
FONSI...............................  Finding of No Significant Impact.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
GED.................................  Graduated Electronic Decelerator.
mA..................................  Milliampere.
MSW.................................  Municipal Solid Waste.
PBS.................................  Positive Behavioral Support.
PTSD................................  Post-traumatic Stress Disorder.
SIB.................................  Self-Injurious Behavior.
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III. Background

    FDA is proposing to ban certain devices that apply a noxious 
electrical stimulus to attempt to reduce or stop undesirable, injurious 
behaviors frequently manifested by vulnerable people. Specifically, 
this rulemaking would ban ESDs for SIB or AB because the devices 
present an unreasonable and substantial risk of illness or injury that 
cannot be corrected or eliminated by labeling or a change in labeling. 
This is the second ban on these devices we are undertaking to protect 
and promote the public health. As we will explain in more detail, the 
U.S. Court of Appeals for the District of Columbia Circuit (D.C. 
Circuit) vacated the first ban.

A. Introduction

    ESDs for SIB or AB give people an often-painful electric shock to 
try to make them stop behaving in ways that are harmful and/or 
dangerous and that are often related to other underlying intellectual 
or developmental disabilities. More specifically, ESDs are a type of 
aversive conditioning device that apply a noxious electrical stimulus 
(the shock) to a person's skin in an attempt to reduce or cease self-
injurious or aggressive behaviors. SIB commonly includes head-banging, 
hand-biting, excessive scratching, and picking of the skin. However, 
SIB can be more extreme and result in bleeding; broken, even protruding 
bones; blindness from eye-gouging or poking; other permanent tissue 
damage; or injuries from swallowing dangerous objects or substances. AB 
can involve repeated physical assaults and can be a danger to the 
individual, others, or property. In this proposed rule, like much of 
the scientific literature, we discuss SIB and AB in tandem and use the 
phrase ``SIB or AB'' to refer to SIB, AB, or both. A more detailed 
discussion of SIB and AB and intellectual or developmental disabilities 
as they relate to individuals with SIB or AB can be found in section 
I.B of the previous proposed rule to ban these devices (2016 Proposed 
Rule) (81 FR 24386 at 24389).
    ESDs that are subject to this proposed ban are intended to reduce 
SIB or AB according to the principle of aversive conditioning. Aversive 
conditioning pairs a noxious stimulus (such as, here, a noxious 
electric shock delivered to an individual's skin) with a target 
behavior; the goal is that the individual eventually associates the 
noxious stimulus with the behavior. Pairing a target behavior with 
shocks from an ESD is intended to affect behavior in two ways: by 
interrupting the target behavior as an immediate response to the 
stimulus--for example, in response to pain--and, over time, through a 
conditioned reduction in the target behavior if the person learns to 
associate the shock with the target behavior (and can learn to control 
the behavior). Associating the unwanted behavior with the shock is 
intended to decrease the frequency of the behavior or stop it 
altogether.
    However, as explained here, ESDs pose a number of serious risks and 
have not been shown to be effective, and modern treatments for SIB or 
AB have been generally successful without involving the use of ESDs. 
State-of-the-art treatments instead include conducting a functional 
behavioral assessment to determine the causes and triggers of self-
injury or aggression, then using that information to design a plan with 
supportive approaches, consisting of multiple elements, to modify the 
behavior. In some cases, pharmacotherapy is an appropriate element of a 
treatment plan, depending on the specific patient. These approaches 
have generally been successful, even for some of the most difficult 
cases. The use of ESDs was mostly abandoned decades ago, in part 
because the shocks can be painful or very painful for the recipients. 
Only one facility in the United States still applies these devices to 
individuals.
    Although in 2018 a Massachusetts court found, for the purpose of 
considering whether to lift a consent decree, that there was no 
professional consensus as to whether ESDs are part of standard of care 
for treating individuals with intellectual and developmental 
disabilities,\1\ the professional consensus regarding the accepted 
standard of care and such use of ESDs is not an issue in this 
rulemaking (see discussion in the 2020 Final Rule, 85 FR 13312 at 13314 
through 13315). Rather, to ban a device

[[Page 20885]]

under section 516 of the FD&C Act (21 U.S.C. 360f), FDA must determine 
the device presents an ``unreasonable and substantial risk of illness 
or injury.'' In making this determination, FDA analyzes whether the 
risks the device poses to individuals are important, material, or 
significant in relation to its benefits to the public health, and FDA 
compares those risks and benefits to the risks and benefits posed by 
alternative treatments being used in current medical practice (which 
relates to what FDA refers to as ``the state of the art'') (85 FR 13312 
at 13315; 81 FR 24386 at 24388). The purpose of considering the 
alternatives used in current medical practice to treat a particular 
patient population is to assess and compare the risks and benefits of 
those alternatives to the risks and benefits of the device that is the 
subject of the ban, not to determine whether the device that is the 
subject of the ban is part of the standard of care or state of the art. 
For these reasons, as stated in the 2020 Final Rule, whether 
punishment, contingent shock, or ESDs are within the standard of care 
or state of the art is not an issue in this rulemaking (85 FR 13312 at 
13341). In sum, the court's decision has no legal or scientific bearing 
on this proposed ban.
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    \1\ On September 7, 2023, the Supreme Judicial Court of 
Massachusetts considered the narrow question of whether the probate 
judge abused her discretion in making that finding based upon the 
evidence before her at the time of that decision (all of which was 
from 2016 and earlier), and concluded that she had not. See Judge 
Rotenberg Educational Center, Inc. v. Commissioner of the Department 
of Developmental Services, 492 Mass. 772 (September 7, 2023).
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B. Need for the Regulation

    This rulemaking would protect and promote the public health by 
banning ESDs for SIB or AB, which would prevent this patient population 
from being subjected to a device that poses a substantial and 
unreasonable risk of illness or injury. As we explained in the previous 
rulemaking to ban ESDs for SIB and AB, people who manifest SIB or AB 
often have intellectual and developmental disabilities including, but 
not limited to, autism spectrum disorder, Down syndrome, or Tourette 
syndrome, as well as other cognitive or psychiatric disorders and 
severe intellectual impairment (including a broad range of intellectual 
measures) (see, e.g., 81 FR 24386 at 24389). Notably, some people with 
such intellectual and developmental disabilities may have difficulty 
communicating and may not be able to make their own treatment decisions 
because of such disabilities (see, e.g., 85 FR 13312 at 13329). This, 
among other reasons, means that many people who exhibit SIB or AB 
constitute a vulnerable population. For people who manifest SIB or AB, 
ESDs intended for those conditions present a substantial and 
unreasonable risk of illness or injury that cannot be corrected or 
eliminated by labeling or a change in labeling. As such, a ban on these 
devices for these intended uses is warranted.
    As discussed in section IV below, section 516(a) of the FD&C Act 
authorizes FDA to ban a device for one or more intended uses, by 
regulation, if we find, on the basis of all available data and 
information, that such a device presents substantial deception or an 
unreasonable and substantial risk of illness or injury. Accordingly, 
based on the serious risks posed by ESDs for SIB or AB, the inadequacy 
of data to support their effectiveness, and the positive benefit-risk 
profiles of the state-of-the-art alternatives for the treatment of SIB 
or AB, FDA has determined that ESDs present an unreasonable and 
substantial risk of illness or injury that cannot be corrected or 
eliminated by labeling. The proposed rule would apply to devices 
already in distribution and use, as well as to future sale and 
distribution of these devices. The purpose of this notice is to seek 
comments on FDA's proposal to ban ESDs used for SIB or AB and comments 
on any other associated issues. Section V of this document discusses 
the information and data that support these proposed findings.

C. FDA's Current Regulatory Framework

    The FD&C Act, as amended by the Medical Device Amendments of 1976 
(1976 Amendments) (Pub. L. 94-295), establishes a comprehensive system 
for the regulation of medical devices intended for human use. Section 
513 of the FD&C Act establishes three categories (classes) of devices, 
reflecting the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness: class I (general 
controls), class II (special controls), and class III (premarket 
approval) (see 21 U.S.C. 360c).
    In 1979, FDA classified aversive conditioning devices as class II 
(see Sec.  882.5235 (21 CFR 882.5235)), which was consistent with the 
recommendation of the Neurological Device Classification Panel in 1978. 
Class II devices are those devices for which general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including the 
promulgation of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions the Agency deems 
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C 
Act).
    Aversive conditioning devices, as a device type, administer an 
electric shock or another noxious stimulus to a patient to modify 
undesirable behavioral characteristics (see Sec.  882.5235). Thus, ESDs 
intended for SIB and AB, which administer shocks to modify target 
behaviors, are within the aversive conditioning device classification 
regulation. As discussed in more detail in section I.D. of the previous 
proposed rule (81 FR 24386 at 24391), in the late 1970s, FDA and the 
panelists of the Neurological Device Classification Panel believed that 
performance standards could adequately assure the safety and 
effectiveness of aversives and proposed a classification accordingly. 
We received no comments from the public on the proposed rule, and we 
issued the final rule classifying aversives as proposed at Sec.  
882.5235 (44 FR 51726 at 51765, September 4, 1979).
    As we explained during the previous rulemaking to ban ESDs for SIB 
and AB, and as remains true, FDA now has a better understanding of the 
risks and benefits presented by these devices than we did 44 years ago 
when these devices were classified. As summarized in section III.B and 
explained more fully in section V.E. of the 2020 Final Rule, the state 
of the art for the treatment of SIB and AB has progressed significantly 
over that time period (85 FR 13312 at 13337 through 13344). The 
development of the scientific literature and treatments for these 
conditions only underscores that the risk of illness or injury from the 
use of ESDs for SIB and AB is unreasonable and substantial.

D. History of the Rulemaking

    FDA previously banned ESDs for SIB and AB in a final rule issued on 
March 6, 2020, pursuant to the Agency's authority under section 516 of 
the FD&C Act (85 FR 13312 at 13354). Specifically, section 516 of the 
FD&C Act provides that FDA may ban a device intended for human use if 
the Agency determines that the device presents substantial deception or 
an unreasonable and substantial risk of illness or injury that cannot 
be corrected or eliminated by labeling or change in labeling. Leading 
up to the final ban, FDA held a public meeting of the Neurological 
Devices Panel of the Medical Devices Advisory Committee on April 24, 
2014 (see 79 FR 17155, March 27, 2014) (Ref. 1), issued a proposed ban 
in the Federal Register of April 25, 2016, and considered comments on 
the proposal from interested stakeholders (81 FR 24386). These 
activities garnered significant interest, and FDA received and reviewed 
voluminous information to develop the final rule banning ESDs for SIB 
and AB.

[[Page 20886]]

    FDA issued the 2020 ban because we determined, based on all 
available information and data at that time, that ESDs for SIB or AB 
present an unreasonable and substantial risk of illness or injury that 
cannot be corrected or eliminated by labeling or a change in labeling. 
FDA found the weight of the evidence indicates that ESDs for SIB or AB 
present a number of psychological and physical risks. We determined the 
evidence does not establish that ESDs improve the underlying causative 
disorder or effectively condition individuals to achieve durable 
reduction of SIB or AB for a clinically meaningful period of time. FDA 
also found the weight of the evidence indicates that the state-of-the-
art treatment for individuals with SIB or AB relies on multielement 
positive interventions, for example, paradigms such as positive 
behavior support (PBS) or dialectical behavioral therapy (DBT), 
sometimes in conjunction with pharmacological treatments (85 FR 13312 
at 13315 and 13337). Even in cases in which behavioral modification 
plans include punishment techniques, the techniques are significantly 
less intrusive than ESDs and do not inflict pain; for example, they 
include timeouts.
    Following the publication of the 2020 ban, the sole manufacturer 
and only facility to use ESDs for SIB and AB, The Judge Rotenberg 
Educational Center, Inc. (JRC), challenged in court FDA's authority to 
issue the 2020 ban. On July 6, 2021, the D.C. Circuit vacated the 2020 
ban. See Judge Rotenberg Educational Center, Inc. v. FDA, 3 F.4th 390 
(D.C. Cir. 2021). The court interpreted section 516 of the FD&C Act, as 
it existed at the time, and section 1006 of the FD&C Act, as not 
permitting FDA to ban devices for specific intended uses, in that 
instance ESDs for SIB or AB, without banning the device for all 
intended uses.
    Following the court's decision, Congress enacted the Food and Drug 
Omnibus Reform Act of 2022 (FDORA) (Pub. L. 117-328). FDORA amended 
section 516(a) of the FD&C Act to expressly state that FDA's authority 
to ban a device intended for human use includes the authority to ban a 
device for one or more intended uses, and that a device banned for one 
or more intended uses is not a legally marketed device under section 
1006 of the FD&C Act. As amended, the statute is clear that FDA may 
issue a ban such as the previous ban on ESDs for SIB or AB, which 
applies to one or more specific intended uses. After reviewing 
publications and other information that have become known to the Agency 
in the brief interim between the issuance of the previous ban in 2020 
and now, and determining that it does not change our conclusion that 
ESDs for SIB or AB present an unreasonable and substantial risk of 
illness or injury that cannot be corrected or eliminated by labeling or 
a change in labeling, FDA is proposing to ban ESDs intended for SIB or 
AB under section 516 of the FD&C Act, as amended.

IV. Legal Authority

    Under section 516 of the FD&C Act, FDA may ban a device by 
regulation if we find, on the basis of all available data and 
information, that such a device with the relevant intended use(s) 
presents substantial deception or an unreasonable and substantial risk 
of illness or injury that cannot be corrected or eliminated by labeling 
or change in labeling (see 21 U.S.C. 360f(a)(1) and (2), as amended by 
section 3306 of FDORA).
    Section 3306 of FDORA expressly provides that FDA has the authority 
to ban a device for one or more intended uses and that FDA's authority 
under section 516 of the FD&C Act is not limited only to bans of a 
device for all of its intended uses. The legislative history reinforces 
that section 516 of the FD&C Act, as amended, authorizes FDA to ban a 
device regardless of whether or not the ban includes other devices that 
are technologically similar but have different intended uses (see H. 
Rept. 117-348 at 65). The regulatory status of a device has long 
depended on its intended use(s), even before the enactment of the 1976 
Amendments (see id.). A product's status as a device regulated by FDA, 
along with its classification, premarket pathway, labeling, and other 
requirements all ``very much depend on its intended use'' (id. at 65-
66). The amendment to section 516 of the FD&C Act makes clear that the 
same principle applies to FDA's banning authority, permitting FDA to 
ban certain intended use(s) of a type of technology that meet the 
standard to ban devices, while not banning others that do not (see id. 
at 66).
    A banned device, as defined in part by its intended use(s), is 
adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)), 
except to the extent it is being studied pursuant to an investigational 
device exemption under section 520(g) of the FD&C Act (21 U.S.C. 
360j(g)). The FD&C Act defines various prohibited acts respecting 
adulterated devices (see 21 U.S.C. 331).
    This proposed rule is also issued under section 701(a) of the FD&C 
Act, which provides FDA authority to issue regulations for the 
efficient enforcement of the FD&C Act (see 21 U.S.C. 371(a)). This 
rule, if finalized, would enable FDA to efficiently enforce the FD&C 
Act.
    Part 895 sets forth the regulations that apply to banning devices 
under section 516 of the FD&C Act. Consistent with those regulations 
(and other applicable legal provisions), we are proposing findings, 
based on all available information and data, that ESDs for SIB or AB 
present a substantial and unreasonable risk of illness or injury.
    In determining whether a risk of illness or injury is 
``substantial,'' FDA considers whether the risk posed by the continued 
marketing of the device, or continued marketing of the device as 
presently labeled, is important, material, or significant in relation 
to the benefit to the public health from its continued marketing (see 
Sec.  895.21(a)(1) (21 CFR 895.21(a)(1))).
    Although FDA's device banning regulations do not define 
``unreasonable risk,'' we explained in the preamble to the final rule 
establishing part 895 that, with respect to ``unreasonable risk,'' we 
will conduct a careful analysis of risks associated with the use of the 
device relative to the state of the art and the potential hazard to 
patients and users (44 FR 29214 at 29215, May 18, 1979). The state of 
the art with respect to this rule is the state of current technical and 
scientific knowledge and medical practice with regard to the treatment 
of patients exhibiting self-injurious and aggressive behavior.
    Thus, in determining whether a device presents an ``unreasonable 
and substantial risk of illness or injury'' for one or more intended 
uses, FDA analyzes the risks and the benefits the device poses to 
individuals when used for such intended use or uses, comparing those 
risks and benefits to the risks and benefits posed by alternative 
treatments being used in current medical practice. Actual proof of 
illness or injury is not required; FDA need only find that a device 
presents the requisite degree of risk on the basis of all available 
data and information (H. Rept. 94-853 at 19; 44 FR 29214 at 29215).
    If FDA determines that the risk can be corrected through labeling, 
FDA will notify the responsible person of the required labeling or 
change in labeling necessary to eliminate or correct such risk (see 21 
CFR 895.25). Because FDA is proposing to determine that the risk 
associated with using ESDs for SIB or AB cannot be corrected or 
eliminated by labeling, we are not at this time notifying responsible 
persons regarding labeling. If FDA finalizes this ban as proposed, ESDs 
intended for SIB or AB

[[Page 20887]]

will be adulterated and not legally marketed within the meaning of 
section 1006 of the FD&C Act when intended for SIB or AB.
    To ban a device intended for human use, Sec.  895.21(d) requires 
that a proposed ban briefly summarize:
     the Agency's findings regarding substantial deception or 
an unreasonable and substantial risk of illness or injury;
     the reasons why FDA initiated the proceeding;
     the evaluation of the data and information FDA obtained 
under provisions (other than section 516) of the FD&C Act, as well as 
information submitted by the device manufacturer, distributer, or 
importer, or any other interested party;
     the consultation with the classification panel;
     the determination that labeling, or a change in labeling, 
cannot correct or eliminate the deception or risk;
     the determination of whether, and the reasons why, the ban 
should apply to devices already in commercial distribution, sold to 
ultimate users, or both; and
     any other data and information that FDA believes are 
pertinent to the proceeding.
    The previous proposed and final ban on ESDs for SIB or AB describe 
this information extensively, and we do not repeat that information in 
full here. Instead, because the primary change in circumstances leading 
to this rulemaking is of a legal (not scientific) nature, this proposed 
rule references the information and findings from the previous 
rulemaking and briefly summarizes that information with reference to 
the previous proposed rule, final rule, or both, as applicable. In 
addition, this proposed rule discusses the new data and information 
that FDA has become aware of since the 2020 Final Rule.
    FDA notes that, although a banned device or banned intended use of 
a device is not barred from clinical study under an investigational 
device exemption pursuant to section 520(g) of the FD&C Act, any such 
study must meet all applicable requirements. These include, but are not 
limited to, requirements for: protection of human subjects (21 CFR part 
50), financial disclosure by clinical investigators (21 CFR part 54), 
approval by institutional review boards (21 CFR part 56), and 
investigational device exemptions (21 CFR part 812).

V. Evaluation and Discussion of Data and Information

    FDA has determined, on the basis of all available data and 
information, that ESDs for SIB or AB present a substantial and 
unreasonable risk of illness or injury. Given the relatively short 
amount of time since the previous ban that we finalized in 2020, there 
is very little relevant data or information that we have not already 
considered and discussed in the previous rulemaking. The few 
publications and other information that have become known to the Agency 
in the brief interim between the issuance of the previous ban in 2020 
and now do not change our conclusions regarding the risks or effects of 
ESDs for SIB or AB or the state of the art of treatment for this 
patient population. We are therefore referencing our previous 
discussion and findings (81 FR 24386 at 24386 through 24412 and 85 FR 
13312 at 13312 through 13349) in this rulemaking and supplementing them 
with an explanation of how since-developed data and information have 
added to our understanding of the relevant issues. We also are 
associating with this rulemaking the public dockets created for the 
previous rulemaking (Docket No. FDA-2016-N-1111) and the Neurological 
Devices Panel of the Medical Devices Advisory Committee on April 24, 
2014 (Docket No. FDA-2014-N-0238) and consider them part of this 
proposed rule. All of the documents associated with Docket No. FDA-
2016-N-1111 and Docket No. FDA-2014-N-0238 are contained in the docket 
for this proposed rule as well. With regard to the available data and 
information, this proposed rule therefore focuses on new information 
and data that we have become aware of since we issued the previous ban.
    To identify and assess information that we had not previously 
considered, we conducted a search for literature on the risks and 
effects of ESDs for SIB or AB published since our systematic literature 
review for the 2016 Proposed Rule and again assessed the state of the 
art for treating SIB or AB.
    Our search returned the following new sources: (1) 5 research 
studies (3 case reports, an open label add-on study, and a 
retrospective chart review); (2) 4 policy or consensus statements; a 
task force report; (3) 11 commentaries by researchers, academics, or 
practitioners; (4) a set of practice guidelines; (5) a followup survey 
of 88 former patients of JRC that did and did not have ESDs as part of 
their treatment plans; (6) and a meta-analysis. FDA weighed the new 
information according to the same factors that we explained in the 2016 
Proposed Rule and 2020 Final Rule.
    During the development of the 2020 Final Rule, in the form of 
comments to the docket, JRC provided the Agency with several JRC 
studies, information, and numerous records of patients with SIB or AB 
whose treatment plans include ESD use. Of the five new research 
studies, four are authored or coauthored by JRC staff. The four JRC 
research studies appear to be based largely on this same information 
and patient data and, as discussed in sections V.A and B, have many of 
the same significant limitations identified by FDA as the previously 
submitted studies, meaning the studies are less likely to support 
confidence in generalizable results than studies with more 
scientifically sound designs and methodologies. As a result, while the 
publication process adds some reassurances to the credibility of the 
information and data, presenting previously submitted data in a 
different form does little to add to overall knowledge about the risks 
and effects of ESDs for SIB or AB.
    Generally speaking, little new information or data have developed 
since our previous consideration of banning ESDs for SIB or AB. 
Nonetheless, the new material is consistent with the evidence FDA 
previously considered regarding the risks presented by this device, the 
lack of evidence of its effectiveness for the treatment of SIB or AB, 
and the state of the art for treating SIB or AB, which includes 
successful interventions that are less restrictive and lower risk, as 
has been the case for decades (85 FR 13312 at 13341). Accordingly, we 
have again found that the devices present a substantial and 
unreasonable risk of illness or injury that cannot be corrected or 
eliminated by labeling or change in labeling.

A. Risks of ESDs for SIB or AB

    The new studies and other materials that FDA reviewed are 
consistent with our previous findings regarding the risks of ESDs for 
SIB or AB, including likely underreporting of adverse events (AEs). As 
explained in the 2016 Proposed Rule and 2020 Final Rule, the risks 
presented by ESDs are both psychological (including suffering) and 
physical (including pain), each having a complex relationship with the 
electrical parameters of the shock. The subjective experience of the 
person receiving the shock can therefore be difficult to predict. 
Physical reactions roughly correlate with the peak current of the shock 
delivered by the ESD. However, various other factors such as sweat,

[[Page 20888]]

electrode placement, recent history of shocks, and body chemistry can 
physically affect the sensation. As a result, the intensity or pain 
experienced by an individual from a particular set of shock parameters 
can vary greatly from patient to patient and from shock to shock. More 
information about the relationship between the electrical parameters of 
the shock and conditions that may affect patient perception can be 
found in section I.C. of the 2016 Proposed Rule (81 FR 24386 at 24390 
through 24391) and Response 14 of the 2020 Final Rule (85 FR 13312 at 
13322).
    Possible adverse psychological reactions are even more loosely 
correlated with shock strength or intensity (85 FR 13312 at 13322). To 
cause such adverse reactions, the shock needs to be subjectively 
stressful enough to cause trauma or suffering, which does not 
necessarily require a strong shock. Trauma becomes more likely, for 
example, when the recipient does not have control over the shock or has 
developed a fear of future shocks, neither of which is an electrical 
parameter of the shock. A more detailed explanation of these phenomena 
can be found in the 2016 Proposed Rule (81 FR 24386 at 24387) and the 
2020 Final Rule (85 FR 13312 at 13324 through 13325).
    To summarize, FDA found that the medical literature shows ESDs 
present a number of psychological harms including depression, PTSD, 
anxiety, fear, panic, substitution of other negative behaviors, 
worsening of underlying symptoms, and learned helplessness (becoming 
unable or unwilling to respond in any way to the ESD); and the devices 
present the physical risks of pain, skin burns, and tissue damage.
    FDA also considered risks identified through other sources, such as 
experts in the field, State agencies that regulate ESD use, and records 
from the only facility that has recently manufactured and is currently 
using ESDs for SIB or AB. These sources further support the reports of 
risks in the literature and indicate that ESDs pose additional risks 
such as suicidality, chronic stress, acute stress disorder, neuropathy, 
withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, 
insensitivity to fatigue or pain, changes in sleep patterns, loss of 
interest, difficulty concentrating, and injuries from falling (85 FR 
13312 at 13315). For more information about FDA's analysis regarding 
the risks of ESDs for SIB and AB, see section V.C. of the 2020 Final 
Rule (85 FR 13312 at 13321 through 13332).
    We also concluded that the medical literature likely underreports 
AEs. This is attributable to several factors including the small number 
of subjects in the studies, many of whom have impaired ability to 
demonstrate and communicate AEs; potential attribution by clinicians of 
adverse effects to the patients' cognitive, intellectual, or 
psychiatric conditions rather than to the device; methodological 
limitations such as study design and the lack of a prespecified 
systematic plan for monitoring AEs; and researcher bias (81 FR 24386 at 
24395 through 24396; 85 FR 13312 at 13329 and 13331).
    The new sources that are based largely on data and information that 
FDA previously reviewed when developing the 2020 Final Rule support our 
previous determinations for the 2020 Final Rule about the types of 
risks posed by ESDs for SIB or AB. As a result, these new sources do 
not significantly affect our previous assessment of risks. 
Specifically, one meta-analysis of 150 reports and studies (Ref. 2) and 
four commentaries (Refs. 3 to 6), including one by a JRC staff member, 
report AEs associated with ESDs for SIB or AB. These sources identify 
the following physical and psychological risks:
     pain (Refs. 2, 3, 5);
     escape or avoidance responses (Refs. 3 and 5);
     extreme anxiety manifesting as screaming, crying, negative 
vocalizations when ESD was implemented, and attack (Refs. 3 and 5);
     tensing of the body (Ref. 3);
     emotional behavior (Ref. 3);
     fear (Refs. 4 to 6);
     feeling terrorized (Ref. 6);
     panic (Ref. 5);
     ``freezing'' (Ref. 5);
     attempts to remove the device (Ref. 5);
     distress (Refs. 2 and 4);
     burns (Refs. 3 and 6);
     tremor in the thigh during activation (Ref. 3); and
     temporary skin discoloration (Ref. 3).
    In addition, the new sources based primarily on data and 
information that FDA had not previously reviewed for the 2020 Final 
Rule generally support these risks. A task force of the Association for 
Behavior Analysis International (ABAI) reports pain and attempts to 
remove the device (Ref. 7) and two of the studies (Refs. 8 and 9) 
report pain, escape/avoidance, and/or temporary anxiety, as noted 
below. While some of these new sources suggest that there is no strong 
evidence of negative ``side effects'' of ESDs based on research to date 
(Ref. 7) or no occurrence of AEs (Ref. 8), these conclusions are based 
on studies that have significant limitations, as discussed below and in 
the previous rulemaking (81 FR 24386 at 24400 through 24401). During 
the previous rulemaking, some experts expressed concern about a 
heightened risk of AEs ``from exposing a member of a vulnerable patient 
population to continual, painful shocks over a period of years, in many 
cases several years'' (85 FR 13312 at 13327).
    As discussed in section V.B., the new studies continue to 
demonstrate use of ESDs for lengthy, indefinite periods of time and 
adaptation of some patients to the shocks (they no longer respond to 
shocks), even at the strongest level. The use of ESDs for long periods 
and on patients who have adapted to shocks would provide greater 
opportunity for AEs to occur, or for existing AEs to get worse due to 
cumulative effects, in a population largely consisting of vulnerable 
individuals. A treatment plan that includes use of ESDs for individuals 
with SIB or AB indefinitely (Ref. 10) would further heighten the 
concern about the risks of AEs. As explained further in section V.B., a 
173-patient retrospective chart review study suggests that JRC attempts 
``planned fading'' of ESD use, defined in that study as the removal of 
all ESD devices for any period, for only a relatively few number of 
individuals the attending clinician believes are likely to succeed 
(Ref. 9).\2\ Thus, most of the individuals would continue to accumulate 
exposure to the risks of ESDs for SIB or AB. Further, a decision to use 
ESDs for ``long-term management'' of SIB or AB (Ref. 10) could suppress 
behavior in a manner that masks an underlying medical condition (Ref. 
7). This in turn can affect access to (or the desire to access) 
effective treatments, which itself represents a risk to health.
---------------------------------------------------------------------------

    \2\ According to the study, only 23 of 173 individuals were in 
the planned fading group.
---------------------------------------------------------------------------

    The new sources also add evidence for the likelihood of 
underreporting of AEs for the same reasons we previously found for the 
medical literature reviewed for the 2020 ban: the impaired ability of 
many subjects to demonstrate and communicate AEs, which also increases 
the risk of harm to these individuals; difficulty of practitioners to 
recognize feedback from patients indicating that an AE occurred; 
methodological limitations in the studies; and researcher bias. Thus, 
while some new sources indicate that research ``does not provide strong 
evidence that [ESDs are] associated with negative side effects'' and 
that the ``few studies presenting data on the side effects of [ESDs] 
have reported only

[[Page 20889]]

positive collateral changes in responding,'' (Ref. 7), these 
conclusions need to be viewed with these limitations in mind.
    Like the medical literature considered for the 2020 Final Rule, 
most of the new studies involve a small number of patients, some of 
whom likely would have difficulty communicating or otherwise 
demonstrating AEs, including injuries, due to cognitive, intellectual, 
or psychiatric conditions. As noted in the 2016 Proposed Rule (81 FR 
24386 at 24395), this difficulty may prevent providers from recognizing 
feedback from patients indicating that an AE has occurred.
    None of the new studies prospectively planned for the systematic 
observation and collection of data regarding AEs, and very few AEs are 
reported. Only one new study on the use of the GED, the only ESD still 
in use for SIB or AB, identified any AEs (Ref. 9). That study, a 
retrospective chart review of 173 patients authored by JRC staff, 
reports only what the authors ``anecdotally'' found were ``the most 
common side effects'': escape/avoidance responses and temporary anxiety 
during the period between occurrence of the behavior and the 
``programmed consequence,'' i.e., shock (Ref. 9). The study reports 
that staff members who administered shocks were ``prompted to report 
any adverse conditions,'' and acknowledges that ``a standardized a 
priori system was not employed'' for monitoring AEs (Ref. 9). Thus, the 
study does not report systematic, recorded counts of adverse events 
based on specific identification or followup protocols. Rather, it 
reports the authors' subjective opinion in hindsight. Three of the 
other new studies, two of which were authored or coauthored by JRC 
staff, include no assessment of AEs (Refs. 10 to 12).
    The remaining new study, a case report coauthored by JRC staff, 
reports ``no evidence of physical or psychological adverse effects when 
GED is administered per protocol'' (Ref. 8). Despite that statement, 
the study lists temporary pain as a ``con'' of GED use. Further, the 
JRC coauthor of the study, who is also coauthor of three of the other 
new studies, continues to acknowledge that ``[t]he obvious effect of 
[the ESD] is pain caused when electrical current stimulates nociceptors 
and sensory receptors'' (Ref. 3). As explained in the 2016 Proposed 
Rule and 2020 Final Rule, FDA considers pain to be an AE. Such biases 
against recognizing and/or recording certain harms as AEs creates doubt 
that the studies adequately considered AEs and, therefore, the risks of 
the device. Such biases also would impair an accurate benefit-risk 
assessment; undesirable effects should not be presumed unavoidable, 
much less go unaccounted for, even if they ultimately prove to be 
reasonable. The pain ESDs cause is relevant because, although ESDs are 
intended to apply an aversive stimulus, the pain they cause to attempt 
to develop the aversion is nevertheless harmful.
    All of the new studies are retrospective reviews of clinical 
experience, not prospective studies. While retrospective reviews can be 
informative, creating a plan to identify AEs in a standardized, 
forward-looking way and ensure a comprehensive record from the outset 
will generally provide much stronger support for a conclusion that a 
lack of reported AEs means a lack of AEs to report.
    As with the earlier studies, researcher bias and author conflicts 
of interest also may have contributed to underreporting of AEs. As 
indicated in section III.D., JRC is the sole manufacturer and only 
facility to use ESDs for SIB or AB. Four of the five new studies that 
looked at ESDs for SIB or AB were authored or coauthored by current JRC 
staff and may have minimized AEs. As noted earlier, only one study 
reports any AEs experienced by patients and limits reporting only to 
the ``most common side effects,'' of which pain was not included (Ref. 
9).
    The other new sources that FDA reviewed also suggest a lack of 
attention to the careful and systematic assessment of AEs in research 
involving ESDs, and more generally, in research involving 
intellectually and developmentally disabled individuals (Refs. 2, 4 to 
6, 8, and 13 to 17). For instance, one meta-analysis looking at 
reporting of AEs in research involving young autistic children notes 
that ``[s]tudies of effectiveness did not systematically define, 
monitor, or measure adverse events; instead they were reported in an ad 
hoc fashion and considered tangential to the studies'' (Ref. 2). 
Another author discussing research involving autistic individuals 
opines that the inadequate attention to and examination of harms 
amounts to ``negligent reporting'' (Ref. 13). While not all individuals 
with SIB or AB are autistic, this information informs our general 
understanding of the limitations in research involving individuals with 
intellectual and developmental disabilities. This information tends to 
show that research that, in general, involves people who have 
difficulties communicating and, more specifically, involves the use of 
ESDs for SIB or AB, often does not provide a complete picture of AEs.
    Given the foregoing, FDA has not changed its determination that AEs 
very likely have been underreported in the literature. More information 
about FDA's prior conclusion that AEs likely are underreported in the 
literature can be found in the 2020 Final Rule at Responses to Comments 
26-29 of (85 FR 13312 at 13329 through 13332).
    Thus, based on the totality of the information available to FDA, 
our determination regarding the risks posed by ESDs for SIB or AB 
identified in the 2020 Final Rule has not changed.

B. Effects of ESDs for SIB or AB

    The new information that FDA reviewed does not change our previous 
determinations regarding effectiveness of ESDs for SIB or AB. For the 
2020 Final Rule, FDA determined that some individuals subject to ESDs 
may exhibit an immediate interruption of the targeted behavior if the 
shock is applied while the behavior is occurring, assuming the 
individual has not adapted to the shocks (85 FR 13312 at 13333). 
However, we also determined that the available evidence does not 
establish that ESDs improve the underlying causative disorder or 
condition an individual to achieve a durable reduction of SIB or AB for 
a clinically meaningful period of time (85 FR 13312 at 13333). A 
durable effect is one where an individual develops a conditioned 
response, so the target behavior, along with the frequency of shocks, 
is significantly reduced over a clinically meaningful period of time, 
either while the individual continues to wear the ESD or after the ESD 
is removed.
    As we discussed in the 2020 Final Rule (see 85 FR 13312 at 13332), 
FDA found some information in the scientific literature to suggest ESDs 
may reduce SIB and AB in some individuals. However, as we explained, 
the evidence cannot be generalized and is insufficient to demonstrate 
effectiveness because the studies suffer from serious limitations that 
limit confidence in the results, including weak design, small size, 
confounding factors, outdated standards for conduct, and study-specific 
methodological limitations. As discussed in the 2016 Proposed Rule, 
generally a study's strength or weakness is related to design in a 
number of ways, particularly through randomization, control, and the 
number of study subjects. There have been no large, randomized, and 
controlled trials, or even any large or randomized trials, of

[[Page 20890]]

ESDs for SIB or AB.\3\ Although there have been some studies with some 
level of controls, the controls have been inadequate for effectiveness 
to be demonstrated and they suffer from other significant limitations. 
For further discussion about the strengths and weaknesses of study 
designs and the limitations in the literature previously reviewed by 
FDA, see section II.B.2 of the 2016 Proposed Rule (81 FR 24386 at 24400 
through 24401) and responses to Comment 33 of the 2020 Final Rule (85 
FR 13312 at 13332 through 13333).
---------------------------------------------------------------------------

    \3\ A randomized controlled trial is prospective; the researcher 
creates different conditions across groups at the outset and will 
observe outcomes in the future. The researcher will eventually 
compare the outcomes across groups, with the control group providing 
confidence that the researcher-set conditions were responsible for 
any differences.
---------------------------------------------------------------------------

    For instance, as discussed in the previous rulemaking, one study 
used a prospective case-control design. In addition to not being 
randomized, the study also suffers from significant methodological 
limitations. The study was not blinded, the sample size was extremely 
small, and an unvalidated surrogate endpoint (decrease in mechanical 
restraint rather than a direct measure of SIB) was used as the primary 
outcome measure (81 FR 24386 at 24400; 85 FR 13312 at 13333). The study 
also did not systematically assess AEs (85 FR 13312 at 13329).
    FDA also reviewed a retrospective chart review during the previous 
rulemaking. Retrospective reviews are often considered a relatively 
weaker design because they do not include a control group. The study 
also suffers from various methodological limitations that affected the 
weight of the evidence (see 81 FR 24386 at 24401). The bulk of the 
scientific articles reviewed during the prior rulemaking suggesting 
effectiveness of ESDs for SIB and AB were case reports or series. Case 
reports or series are even weaker than retrospective chart reviews 
because they report on, and attempt to explain, the experiences of very 
few, or even single, individuals (81 FR 24386 at 24400). Further, 
designs that take an outcome as given and then work backwards in an 
attempt to explain it are more vulnerable to bias than prospective 
designs.
    As explained in the 2016 Proposed Rule, conclusions drawn from 
study designs that are not randomized or controlled are generally 
considered weaker because they do not rule out other causes for any 
differences in results, including selection bias, as effectively as 
other study designs. Many factors contribute to the manifestation or 
reduction of target behaviors and therefore can be significantly 
confounding (81 FR 24386 at 24400). It is difficult to draw conclusions 
regarding the effectiveness of ESDs from a study that does not control 
for such confounding factors. Studies that do not plan for the 
systematic observation and collection of data about AEs also may 
overemphasize benefits, unduly implying greater safety and 
reasonableness of the risks because such a study would not fully 
account for the risks. Such studies will yield weaker conclusions with 
respect to the benefit-risk profile. As noted in the 2016 Proposed 
Rule, in the case of ESDs used for SIB or AB, randomization, control, 
large numbers of subjects, and AE reporting are critical to 
understanding the benefit-risk profile (81 FR 24386 at 24400).
    The Agency also has had concerns regarding the fact that some of 
the authors of such studies and a member of one publication's editorial 
board were affiliated with JRC, which suggests potential researcher 
bias and conflicts of interest (81 FR 24386 at 24401). For more 
information on the limitations identified by FDA in the medical 
literature FDA considered for the 2020 Final Rule, see the 2016 
Proposed Rule (81 FR 24386 at 24400 and 24401) and Responses 31 and 33 
in the 2020 Final Rule (85 FR 13312 at 13332 and 13333).
    As explained in the 2020 Final Rule, the ability to achieve durable 
effects by aversively conditioning behavior is critical to the 
evaluation of the effectiveness of ESDs for SIB or AB (see 85 FR 13312 
at 13333). In its comments in the previous rulemaking, JRC relied on 
its fading of some individuals off ESDs to support its arguments 
regarding the device's ability to condition an individual to achieve a 
durable reduction in SIB and AB. The gradual reduction in the use of 
the device is part of ``fading,'' which would presumably be implemented 
once the individual has associated the target behaviors with the 
noxious stimulus. However, both the previously reviewed and new 
evidence indicate that only a small percentage of individuals at JRC 
(the only facility that applies the devices for SIB or AB) have been 
completely faded off the ESD--and that the device has been used on some 
individuals for years and even decades (see 85 FR 13312 at 13335 and 
13336; Refs. 7 to 9). While one study suggests that there also are a 
number of patients who have tolerated some degree of fading with 
continued availability of the ESD (estimated at 20 percent ranging from 
hours to months) (Ref. 8), the study acknowledges that the percentage 
is only an estimate and suffers from a number of the limitations 
discussed above.
    Among the new studies, the 173-patient retrospective review 
indicates that JRC views fading, defined in that study as the removal 
of all ESD devices for any period, as likely to succeed in only a small 
number of individuals. JRC selects for ``planned fading'' only a small 
percentage of individuals whom JRC assesses to have likely demonstrated 
low rates of problem behaviors over extended periods of time, higher 
rates of alternative behaviors, and the acquisition of new skills (23 
of 173 patients in the study) (Ref. 9). Also, as has been observed in 
the literature, once the ESD is removed, SIB and AB can exceed pre-
baseline levels (85 FR 13312 at 13335). This evidence undermines the 
claim that ESDs are effective for durable behavior conditioning for SIB 
or AB. Further, JRC provided no information regarding clinical 
protocols, treatment plans, or behavior frequencies for individuals 
after they stopped use and left JRC. As explained in the 2020 Final 
Rule, such data are important in order to understand, for example, 
whether behaviors worsened or improved after discontinuation of ESD use 
and whether ESDs or other, non-aversive, treatments are responsible for 
any successes (85 FR 13312 at 13336).
    In the previous rulemaking, FDA also discussed evidence indicating 
that some individuals can experience adaptation to ESD shocks after 
being shocked for some period of time. This means that, to the extent a 
patient may have been responding to ESD shocks, the patient no longer 
responds, at least at the level of shock strength that has been used on 
them. For these individuals, even immediate interruption of behavior 
may not result from use of shocks. Experts in the field consider 
adaptation to be evidence of ineffectiveness (see 85 FR 13312 at 13336 
and 81 FR 24386 at 24399). JRC has acknowledged that adaptation may 
necessitate an alternative method to modify behaviors instead of an ESD 
(see 85 FR 13312 at 13336). As we stated in the 2020 Final Rule, JRC's 
Director of Research at the time said JRC had ``a very comprehensive 
alternative behavior program'' that was ``very effective'' after 
adaptation to the stronger version of JRC's ESD, even for patients 
engaging in SIB that could result in serious injury to themselves (85 
FR 13312 at 13336). That JRC's own providers ultimately turn to 
alternative behavioral programs, even for severe behaviors, speaks both 
to the effectiveness of state-of-the-art approaches and the 
ineffectiveness of applying electrical shocks for SIB or AB.

[[Page 20891]]

    Considering such evidence in the previous rulemaking, FDA concluded 
that the limited data regarding the effects of ESDs for SIB or AB are 
inadequate to demonstrate that ESDs are effective for durable behavior 
conditioning. For more information about FDA's previous determination 
regarding the effects of ESDs on SIB and AB, see section V.D. of the 
2020 Final Rule (85 FR 13312 at 13332 through 13337).
    The information in the new sources does not change the Agency's 
prior determinations about the short- and long-term effects of ESDs on 
SIB or AB. Most of the new studies are authored or coauthored by JRC 
staff and appear to be based on much of the same or similar data JRC 
previously submitted, with similar limitations, albeit presented in a 
different format. As with the studies FDA reviewed for the 2020 Final 
Rule, the new studies similarly suggest some immediate effects of ESDs 
for SIB or AB for some individuals, in particular that the ESDs 
interrupted the target behavior (Refs. 8 to 12). Some commentaries, 
consensus statements, the ABAI task force report, and the 88-patient 
survey also offer some support for the immediate effect of ESDs on 
targeted behavior (although some individuals may not respond and/or may 
adapt to the shock intensity and alternative approaches are used) 
(Refs. 3, 5, 7, 14, 18, and 19). The new studies also conclude that 
ESDs have some level of durable effectiveness for some individuals with 
SIB and AB. Relying on information that FDA previously reviewed and 
some of the new studies discussed in this proposed rule, the ABAI task 
force similarly states that ESDs ``can be effective in suppressing 
problem behavior for up to 5 years'' and that ``responding typically 
remains suppressed under [ESDs] over the long run'' (Ref. 7). However, 
due to the various limitations of these studies as well as the evidence 
indicating adaptation to the device and potentially unending ESD use 
for some individuals, FDA has determined that the evidence still does 
not demonstrate that the devices are effective for durable behavior 
conditioning for SIB or AB for a clinically meaningful period of time, 
much less that they present a favorable benefit-risk profile.
    The new studies suffer from many of the same limitations as those 
studies FDA considered and discussed in the 2016 Proposed Rule and 2020 
Final Rule. The three case report studies (Refs. 8, 11, and 12) and one 
open label add-on trial (Ref. 10) involve a very small number of 
patients (one to four), which makes generalization of any results 
difficult. Four of the five new studies were authored or coauthored by 
JRC staff, which may introduce researcher bias. All of the studies lack 
robust experimental controls and, as explained above, likely 
underreport AEs.
    The new studies also include significant confounding factors, such 
as the presence of concurrent treatments or changes in other treatments 
over a period of time. The JRC 173-patient retrospective chart review 
acknowledges that, ``[d]uring treatment, a given participant may have 
received additional treatments including psychotherapy, 
psychopharmacology, and/or various behavioral interventions.'' The ABAI 
task force report describes one example of an additional treatment, a 
``holster program,'' used by JRC in some cases where a patient adapts 
or does not respond to the GED-4 to decrease problem behavior (see also 
Ref. 8). Individuals in the program receive continuous access to a 
positive reward (preferred videos, music, etc.) for keeping their hands 
in a holster for increasing amounts of time. If they remove their 
hands, the reward will stop, and a shock will be administered. Once the 
individuals can keep their hands in the holsters for 10 minutes, they 
continue to receive regular ``practice sessions'' to ``maintain the 
effectiveness of holster-wearing to decrease problem behavior 
throughout the remainder of the day.'' While wearing the holster during 
the day, if a target behavior occurs, the individual receives a shock 
and a 10-minute holster session (Ref. 7). The description of the 
holster program, while unclear in some particulars, suggests that 
increasing opportunities for positive reinforcement supports any 
reduction of target behaviors. The use of this positive reinforcement 
method introduces a confounding factor in the determination of the 
effectiveness of ESDs; the reward system, rather than the ESD, may have 
induced or helped induce any desirable effects on behavior. 
Alternatively, or perhaps as a complement to the reward system, use of 
the holster may have controlled or helped control the behavior. Other 
concurrent treatments or changes to treatments may have similar 
confounding effects.
    Another limitation of some of the new studies stems from the fact 
that the behaviors targeted for ESD use are not consistent across the 
studies, and they were not limited to SIB or AB. Target behaviors 
spanned a wide range, such as ``members of a chain of behaviors (e.g., 
posturing and threats) that consistently led to the ultimate behavior, 
attempts to engage in the behavior, and vestigial versions of the 
behavior'' (Ref. 9). Thus, vaguely described improvements that may, for 
example, include reductions in ``vestigial versions of the behavior'' 
are not obviously evidence of effectiveness for treating SIB or AB. 
Such claims also speak to a vulnerable population being subject to 
invasive behavioral control techniques; that is, such claims may also 
speak to an increased risk of AEs from an overly broad set of targeted 
behaviors. The sources also indicate that ESDs may be used for other 
categories of behavior such as noncompliant, destructive, and major 
disruptive behaviors as well as attempts to remove the device (Refs. 7, 
9, and 11). Delivering an electric shock, for instance, for disruptive 
behavior is not clearly addressing self-injury or aggression. In the 
same vein, use of the device in an attempt to prevent its removal is 
not only difficult to rely on as evidence of effectiveness for SIB or 
AB, but such use also underscores that vulnerable patients are unable 
to avoid the risks presented by the device, such as pain. This in turn 
can increase other risks, such as the risk of learned helplessness 
(Ref. 20). Such broad target behaviors also suggest that a population 
broader than individuals exhibiting SIB and AB may be subject to the 
invasive behavioral control of ESDs and the risks they present.
    Some studies acknowledge these methodological limitations. The JRC 
173-patient retrospective chart review (Ref. 9) explains that ``a wide 
range of behavior topographies [were] targeted'' because they ``were 
associated with aggression and self-injury,'' and the ``participants 
lacked homogeneity outside of the uniting factor of behavior problem 
severity and refractory nature.'' In other words, the study included 
participants with widely differing behavioral characteristics, although 
their severity was considered similar. The study also recognizes, 
``[t]he participants carried a variety of diagnoses and may have 
responded differently because of their diagnostic classification'' and 
``[v]arious pathophysiological and environmental determinants may lead 
to such behaviors.'' This study also noted, ``the frequency data lacks 
interobserver reliability,'' meaning it did not account for or address 
variability between different observers' subjective judgments. The open 
label add-on trial (Ref. 10) identifies some of the same limitations 
that make it difficult to conclude that any observed reductions in 
target behavior are evidence of effectiveness of ESDs for SIB or AB.

[[Page 20892]]

    New evidence regarding the lengthy, often indefinite, time periods 
that ESDs have been used on individuals and the adaptation of some 
individuals to the shocks further supports our determination that ESDs 
have not been demonstrated to be effective. For example, a four-patient 
case report study suggests that, for some patients, ESDs would be 
indicated indefinitely, similar to insulin for diabetes or 
antiarrhythmic and antihypertensive drugs for cardiovascular disease 
(Ref. 8). The ABAI task force reports that JRC's approach is that 
``most clients will need to receive treatment [with ESDs] for lengthy 
periods of time (5 to 20 years)'' and that ``this does not appear to be 
a treatment that can be effectively faded or discontinued quickly'' 
(Ref. 7). This suggests that the device is not effective for durable 
behavior conditioning for SIB or AB, and is, therefore, not effective 
for its intended use.
    The new sources also support FDA's previous finding that ESDs may 
even lose any immediate effect for some individuals exhibiting SIB or 
AB. The 173-patient retrospective chart review from JRC reports that 
for some participants the ``GED lost efficacy or was only partially 
effective and was substituted for [sic] a more intense stimulus (GED-
4)'' (Ref. 9). The authors note that adaptation was consistent with 
earlier studies that identified habituation to shock intensity by some 
patients and the need for more-intense shocks to eliminate targeted 
behavior. The JRC four patient case report study noted this effect in 
one patient (Ref. 8). The ABAI task force also reported adaptation to 
the ESD based on a visit by members spanning 2 full days in July 2022 
to assess JRC's use of ESDs. The report states that ``[i]n some cases, 
the intensity of the shock must be increased to improve and/or maintain 
its efficacy'' and ``a [JRC] client will be moved from the GED-3 to the 
GED-4 if the GED-3 does not reduce the behavior sufficiently or if the 
client's behavior begins to show habituation to the GED-3'' (Ref. 7). 
According to the report, patients can even habituate, or may not 
respond to, shocks from the GED-4, which provides shocks that are 
significantly stronger than those provided by the GED-3 (41 milliampere 
(mA) vs. 15 mA).
    As a result of such weaknesses and limitations, the available data, 
including the data and information in the new studies and other 
materials, are not sufficient to demonstrate that ESDs for SIB or AB 
are effective for durable behavior conditioning or that they have a 
favorable benefit-risk profile.
    Based upon all available information and data, FDA continues to 
find that while ESDs may result in the interruption and immediate 
cessation of SIB and AB for some individuals if the individual has not 
adapted to the shocks, ESDs have not been demonstrated to be effective 
at improving the underlying condition or conditioning an individual to 
achieve a durable reduction of SIB or AB for a clinically meaningful 
period of time. The evidence does not establish a favorable benefit-
risk profile, and the newer evidence suggesting indefinite use of the 
devices for ongoing management of symptoms may indicate a worse 
benefit-risk profile.

C. State of the Art for Treating SIB or AB

    In determining whether a device presents an unreasonable and 
substantial risk of illness or injury, FDA analyzes the risks and 
benefits that the device poses to individuals relative to the state-of-
the-art of treatment for the intended population--that is, the current 
state of technical and scientific knowledge and medical practice, and 
the potential hazard to patients and users. As explained in the 2020 
Final Rule, FDA found that scientific and medical advances, concerns 
for ethical treatment, and a desire to create generalizable 
interventions that work in community settings led behavioral scientists 
to develop treatments for SIB and AB that are low risk and have 
generally been successful. The available information indicated that 
state-of-the-art treatments of SIB or AB are multielement positive 
interventions (e.g., paradigms such as PBS or DBT), sometimes in 
conjunction with pharmacological treatments, as appropriate (85 FR 
13312 at 13341; 81 FR 24386 at 24410). When restrictive elements or 
punishment techniques were used, they supplemented other behavioral 
intervention elements, were much less intrusive, and were not painful; 
they were considered both compatible with PBS and beneficial (see 85 FR 
13312 at 13341).
    As we said in the 2020 Final Rule, the use of ESDs does not teach a 
person new skills or replacement behaviors, does not mitigate the 
underlying cause of their SIB or AB, and has not been demonstrated to 
be effective for behavioral conditioning, which is especially difficult 
to achieve for those who have conditions that impair their ability to 
understand consequences and react by changing their behaviors. These 
are some of the reasons that the field of applied behavior analysis 
(ABA) as a whole moved away from highly intrusive physical aversive 
conditioning techniques such as ESDs decades ago (85 FR 13312 at 
13340).
    FDA determined that although positive behavioral interventions may 
not always be completely successful in all patients, positive-only 
approaches have low risk and are typically successful, on their own or 
in conjunction with pharmacotherapy, regardless of the severity of the 
behavior targeted or the setting, and can achieve durable long-term 
results while avoiding the risks posed by ESDs (85 FR 13312 at 13315). 
As noted above, when practitioners felt punishment techniques were 
helpful, such techniques were much less intrusive than the use of ESDs; 
for example, they included timeouts, holds, and facial screening (85 FR 
13312 at 13341). For a detailed description of FDA's assessment of 
state-of-the-art treatments for SIB and AB for the 2020 Final Rule, see 
section V.E. of the 2020 Final Rule (85 FR 13312 at 13337 through 
13344) and section II.C. of the 2016 Proposed Rule (81 FR 24386 at 
24403 through 24410).
    The evidence still indicates that positive-only approaches, such as 
approaches based on differential reinforcement and skill-based 
instruction, have been shown to be highly successful in treating many 
types of severe problem behaviors (Ref. 7). Even when ESDs are used for 
SIB or AB, they generally are supplemented by state-of-the-art and/or 
other less intrusive approaches even for severe cases (Ref. 9). An 
example of an alternative treatment that practitioners may turn to if 
an individual habituates to the strongest ESD available is the holster 
program, which is a less intrusive paradigm that increases the use of 
positive rewards. In short, to the extent new information and data bear 
on the state of the art, they underscore why the field as a whole has, 
for decades (81 FR 24386 at 24387), moved away from ESDs and turned 
toward less intrusive techniques to treat SIB or AB effectively (Ref. 
21). Further, the newer information and data emphasize that ESDs are 
not in fact treatments of last resort, even at the facility that has 
previously made such claims. As discussed further in section V.C., the 
ABAI task force reports that JRC rarely conducts analogue functional 
analyses (FAs), despite the fact that experts consider FA the ``gold 
standard'' assessment strategy for problem behavior (Ref. 7). This 
practice suggests that individuals may not experience the ``almost 
unlimited'' range of alternative treatments available (Ref. 7) based on 
an up-to-date, location-specific, comprehensive FA prior to JRC

[[Page 20893]]

incorporating ESDs into their treatment plan. This failure to 
systematically identify and exhaustively implement alternatives 
undercuts the certainty that JRC's patients would not respond to less 
intrusive treatment, are uniquely refractory, and that the devices are 
applied as a last resort, as is suggested by the device labeling.\4\
---------------------------------------------------------------------------

    \4\ The labeling of GED devices includes the statement that 
``[t]he device should be used only on patients where alternate forms 
of therapy have been attempted and failed'' (81 FR 24386 at 24412).
---------------------------------------------------------------------------

    Thus, FDA concludes that state-of-the-art treatment for SIB and AB 
involves positive behavioral techniques, with or without 
pharmacotherapy, and that positive-only approaches have low risk and 
are generally successful even for challenging SIB and AB, in both 
clinical and community settings. Moreover, when punishment techniques 
are used in state-of-the-art behavior modification plans, they are not 
painful and are much less intrusive.

D. Labeling and Correcting or Eliminating Substantial and Unreasonable 
Risks

    After considering all available data and information for the 2020 
Final Rule, FDA determined that labeling or a change in labeling cannot 
correct or eliminate the unreasonable and substantial risk of illness 
or injury of ESDs for SIB or AB (85 FR 13312 at 13344 and 13345). FDA 
further determined that labeling cannot limit the risks to only the 
most refractory patients. The only ESDs for SIB or AB that are 
currently in use, two models of GED manufactured and used by JRC, are 
labeled for use only in individuals refractory to other treatments. 
Such a subpopulation is difficult or impossible to define (85 FR 13312 
at 13332). Further, FDA found the available evidence casts doubt on 
whether the devices are in fact applied as a last resort after 
attempting all other approaches as indicated in the labeling (and as 
claimed by one commenter on the previous proposed rule (JRC)) (Ref. 
22). These determinations remain true after FDA's updated review of the 
available literature.
    More importantly, no subpopulation has been identified in which 
ESDs are effective for SIB or AB or do not pose the risks identified in 
the previous rulemaking and discussed earlier in this document. There 
are also no data suggesting ESDs are more likely to be effective for 
SIB or AB or less likely to pose these risks in a subpopulation that is 
refractory to other treatments or in any other subpopulation. 
Regardless of how the device is labeled, the individual subject to it 
will receive shocks intended to be painful and thereby be subject to 
the physical and psychological risks described in section V.A above, 
without demonstrated effectiveness (see also 85 FR 13312 at 13344).
    Further, individuals with intellectual or developmental 
disabilities may not communicate or be able to communicate information 
for the device user to change the manner in which the device is used to 
correct or eliminate the risks (81 FR 24386 at 24412; 85 FR 13312 at 
13344). Impaired communication of the effects of the device further 
prevents labeling from reducing risks. Accordingly, we concluded that 
no manner of labeling will correct or eliminate the substantial and 
unreasonable risks of these devices (see 81 FR 24386 at 24411 and 
24412; 85 FR 13312 at 13344).
    No additional information has come to FDA's attention indicating 
that labeling or a change in labeling can correct or eliminate the 
substantial and unreasonable risks of these devices. As noted in 
section V.C., the new evidence indicates that JRC rarely conducts FAs 
of patients. This absence of FAs conducted by JRC suggests that the 
existing limiting language in the labeling has little effect on 
mitigating risks by focusing on refractory cases. Indeed, as discussed 
more in section V.B. above, refractory cases at JRC are ultimately 
treated with less invasive approaches suggesting that as used, ESDs are 
not a treatment of last resort. This reinforces our prior 
determinations that labeling specifying a refractory population would 
not correct or eliminate the substantial and unreasonable risk, and 
that there are no labeling changes that would mitigate the risks posed 
by these ESDs.
    Finally, as explained above and in the 2020 Final Rule, no manner 
of labeling will correct or eliminate the risks for patients receiving 
shocks, many of whom may not communicate or be able to communicate 
information about AEs as a result of intellectual or developmental 
disabilities (85 FR 13312 at 13344). The device will continue to 
present the same unreasonable and substantial risk of illness or injury 
for these individuals regardless of the labeling. Based on this 
information and data, FDA concludes that labeling, or a change in 
labeling, cannot correct or eliminate the unreasonable and substantial 
risk of illness or injury of ESDs for SIB or AB.

VI. Description of the Proposed Rule

    We are proposing to amend part 895 by adding Sec.  895.105 to ban 
ESDs for SIB or AB. The proposed rule would ban ESDs intended to treat 
patients with SIB or AB and would cause ESDs intended for these uses 
not to be legally marketed devices, for example, under section 1006 of 
the FD&C Act. We are also proposing conforming edits to Sec.  882.5235 
to exclude ESDs for SIB or AB from the class II designation for 
aversive conditioning devices and instead to indicate that ESDs for SIB 
or AB are banned devices.

A. Applicability (Proposed Sec.  895.105)

    FDA is proposing to ban ESDs that apply a noxious electrical 
stimulus to a person's skin to reduce or stop aggressive or self-
injurious behavior. FDA has determined that these devices present an 
unreasonable and substantial risk of illness or injury that cannot be 
corrected or eliminated by labeling. FDA is not proposing to ban ESDs 
intended for other purposes, such as smoking cessation. ESDs are not 
used in electroconvulsive therapy, sometimes called electroshock 
therapy or ECT, which is unrelated to this rulemaking.
1. Distinguishing Technologically Similar Devices With Different 
Intended Uses
    Note that, although ESDs for SIB or AB may have parallels in 
technology and behavior modification strategy as ESDs for other 
intended uses, ESDs for SIB or AB are distinguishable from other ESDs 
based on several factors. These factors include device design; whether 
patients have control over the shocks and what level of control they 
have; the power output and resulting intensity of the electric shock; 
and how the electric shock affects the patient, target behavior, and 
underlying conditions. For example, a smoking cessation device would 
generally have different output characteristics, resulting in a less 
noxious (perhaps non-painful) shock, where the person affected by the 
shock retains complete control of application of shocks (or could 
immediately revoke consent to the application of shocks). Use of such a 
device without modification for SIB or AB would not be expected to 
induce a response for SIB or AB.
    In contrast, patients exhibiting SIB or AB have no control over 
devices intended for these uses and these devices often deliver a 
painful or very painful shock, strong enough to induce fear and other 
reactions, as opposed to a milder shock from other ESDs. The SIB or AB 
patient is made to carry a stimulus generation module in a waist-pack 
or backpack 24 hours a day, 7 days a week, except during attempts to 
``fade'' the device (although the user,

[[Page 20894]]

not the patient, still decides whether to apply and trigger the 
device). Depending on the targeted behavior, ESDs for SIB or AB use up 
to five electrodes strapped to the arms, legs, torso, and/or feet 
simultaneously, but the locations are not of the patient's choosing 
(see Ref. 7). Shocks are from one electrode at a time, and the 
electrodes are rotated every hour or after discharge, but the patients 
are not able to dictate the rotation for themselves (see Ref. 7). 
Patients subject to ESDs for SIB or AB also have no control over 
whether to withdraw from treatment. Even for patients with mild to no 
intellectual disabilities, evidence indicates that assent from the 
patient is not sought (see Ref. 7). As explained in the 2020 Final 
Rule, lack of control over multiple shocks is an additional risk factor 
because learned helplessness may be more likely when the recipient does 
not have control over the shocks and has previously received multiple 
shocks (85 FR 13312 at 13326). When the recipient does not have control 
over the shocks and has previously received multiple such shocks, 
psychological trauma such as an anxiety or panic reaction can result 
even when the strength is relatively modest (see 85 FR 13312 at 13324 
through 13327).
    Moreover, as explained in the 2020 Final Rule, devices with similar 
technology intended for other uses address different conditions or 
behaviors in different patient populations, and as a result, they 
present different benefit-risk profiles. A device that presents certain 
risks or benefits for one population may not present the same risks or 
benefits, or present them to the same degree, or may present different 
risks or benefits, for a different population. An important 
consideration in the benefit-risk profile of a device is the intended 
patient population and their vulnerabilities. The intended use 
population for ESDs for SIB or AB includes a significant number of 
individuals who have disabilities that present vulnerabilities, such as 
difficulty communicating pain and other harms caused by ESDs. As a 
result of these vulnerabilities, the individual may not communicate or 
be able to communicate information for the device user to change the 
manner in which the device is used to correct or eliminate the risks 
(85 FR 13312 at 13344). In addition, people who exhibit SIB or AB may 
not be able to associate cause and effect or, as with some people with 
an autism spectrum disorder (ASD), they may express pain atypically or 
not at all (85 FR 13312 at 13317). These vulnerabilities are not likely 
to be present in people who use ESDs for other purposes. As a result, 
individuals subject to shocks from an ESD for SIB or AB would bear a 
higher risk of injury or illness from the shock than, for example, 
smokers who choose to use an ESD to help quit smoking (81 FR 24386 at 
24395). Smokers can immediately communicate pain to the device's 
controller or remove the device themselves. They can communicate 
symptoms of other harms that may be caused by ESDs to their healthcare 
provider, which may lead to discontinuation of the device's use, or 
they can decide to stop using the device (85 FR 13312 at 13317).
2. Banning ESDs for SIB or AB That Are Already in Commercial 
Distribution
    FDA is proposing that the ban apply to devices already in 
commercial distribution and use, as well as devices sold or 
commercially distributed in the future (see Sec.  895.21(d)(7)). This 
means ESDs for SIB or AB currently in use on individuals would be 
subject to the ban and thus, upon the effective date of the final rule, 
adulterated under section 501(g) of the FD&C Act and subject to 
potential FDA enforcement action. FDA is proposing this because the 
risk of illness or injury to individuals on whom these devices are 
already used is just as unreasonable and substantial as it is for 
future individuals on whom these devices could be used. Indeed, as the 
development of more beneficial, lower-risk alternative treatments 
continues, the ban's mitigation of the substantial and unreasonable 
risk may be greatest for the individuals on whom ESDs are currently 
used.
    However, as explained in the 2020 Final Rule, for devices already 
in use for SIB or AB, in light of concerns about thorough assessments 
of the behaviors' functions and corresponding development of 
appropriate treatment plans, FDA recognizes that affected parties may 
need some period of time to establish or adjust treatment plans (85 FR 
13312 at 13349). FDA believes that transition off ESDs should occur 
under the supervision of a physician and that the transition should 
occur as soon as possible for the individual. FDA is proposing, for 
devices in use on specific individuals as of the date of publication of 
any final rule based on this proposal, and subject to a physician-
directed transition plan, compliance would be required 180 days after 
the date of publication of any final rule. We welcome comment on how 
long transitions may take.

B. Proposed Conforming Amendment (Sec.  882.5235)

    We are proposing conforming edits to paragraph (b) of Sec.  
882.5235 to exclude ESDs for SIB or AB from the classification of 
aversive conditioning devices into class II. This amendment would 
indicate that ESDs for SIB or AB are banned devices rather than class 
II devices.

VII. Proposed Effective and Compliance Dates

    FDA proposes that any final rule based on this proposed rule be 
effective 30 days after its date of publication in the Federal 
Register.
    FDA proposes that, for devices in use on specific individuals as of 
the date of publication of the final rule and subject to a physician-
directed transition plan, compliance be required 180 days after the 
date of publication of the final rule in the Federal Register. For all 
other devices, FDA proposes that compliance be required 30 days after 
publication in the Federal Register.

VIII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866 
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of [the Office of Information and Regulatory 
Affairs (OIRA)] for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this proposed rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options

[[Page 20895]]

that would minimize any significant impact of a rule on small entities. 
Because the proposed rule would only affect one entity--one that is not 
classified as small--we propose to certify that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes estimates of 
anticipated impacts, before proposing ``any rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The 2022 threshold after adjustment for inflation is $177 
million, using the 2022 Implicit Price Deflator for the Gross Domestic 
Product. This proposed rule would not result in an expenditure in any 
year that meets or exceeds this amount.

B. Summary of Benefits, Costs, and Transfers

    The proposed rule, if finalized, would ban ESDs used for self-
injurious or aggressive behavior. FDA has determined that these devices 
present an unreasonable and substantial risk of illness or injury that 
cannot be corrected or eliminated by labeling or a change in labeling. 
The proposed rule would apply to devices already in distribution and 
use, as well as to future sales and commercial distribution of these 
devices. The costs associated with this proposed rule include costs of 
individuals who are subject to the device if they move to another 
facility or another program within the affected entities. Affected 
entities, who use the device on such individuals, would also incur 
costs from reading and understanding the rule. The present value of 
total estimated costs range between $0.00 million and $68.93 million at 
a 7 percent discount rate, with a primary estimate of $34.47 million. 
At a 3 percent discount rate, the present value of costs range between 
$0.00 million and $80.59 million, with a primary estimate of $40.3 
million. We estimate that the annualized costs over 10 years would 
range from $0.00 million to $9.17 million with a primary estimate of 
$4.59 million at a 7 percent discount rate and a 3 percent discount 
rate.
    The benefits would include avoided negative physical and 
psychological effects from using ESDs on individuals and benefits to 
society in terms of protecting vulnerable populations, which we are not 
able to quantify. We estimate that between 51 to 54 individuals would 
be affected by the proposed rule, if finalized, and benefit from 
avoided adverse effects associated with using ESDs. Any transfers 
associated with the rule would occur if individuals enroll at 
facilities other than the affected entities. The present value of total 
transfer ranges between $0.00 million and $118.26 million at a 7 
percent discount rate, with a primary estimate of $59.13 million. At a 
3 percent discount rate, the present value of transfers ranges between 
$0.00 million and $138.26 million, with a primary estimate of $69.13 
million. The annualized value of transfers range between $0.00 million 
and $15.74 million, with a primary estimate of $7.87 million, at both 7 
percent and 3 percent discount rates. We provide a summary of the 
benefits, costs, and transfers of the proposed rule, if finalized, in 
table 1. We request comment on our estimates of benefits, costs, and 
transfers of this proposed rule.

                                  Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
                                                               [Millions of 2022 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Units
                                                Primary        Low          High    ----------------------------------------------------------
                  Category                      estimate     estimate     estimate                  Discount                                     Notes
                                                                                     Year dollar      rate             Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)..........  ...........  ...........  ...........  ...........           7%
                                                                                                           3%
    Annualized Quantified...................  ...........  ...........  ...........  ...........           7%
                                                                                                           3%
                                             -----------------------------------------------------------------------------------------------------------
Qualitative.................................    Reduction in injuries or adverse psychological effects of ESDs on individuals subject to the
                                                                                          device.
                                             -----------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)..........        $4.59        $0.00        $9.17         2022           7%  10 years
                                                    $4.59        $0.00        $9.17         2022           3%  10 years......................
    Annualized Quantified...................  ...........  ...........  ...........  ...........           7%
                                                                                                           3%
                                             -----------------------------------------------------------------------------------------------------------
    Qualitative.............................       Transition costs to affected entities and individuals for transitioning to alternative
                                                                                        treatments.
                                             -----------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized ($m/year)..  ...........  ...........  ...........  ...........           7%
                                                                                                           3%
    Other Annualized Monetized ($m/year)....        $7.87        $0.00       $15.74         2022           7%  10 years
                                                    $7.87        $0.00       $15.74         2022           3%  10 years......................
                                             -----------------------------------------------------------------------------------------------------------
                                                   From: Affected entities that
                                                     currently use the device
                                                 To: Other facilities that treat
                                              aggressive or self-injurious behavior
                                             -----------------------------------------------------------------------------------------------------------
Effects:                                        State, Local, or Tribal Government: State expenditures may rise or fall if individuals move
                                                                                  across state boundaries
                                             -----------------------------------------------------------------------------------------------------------
                                                                                       Small Business: No effect
                                             -----------------------------------------------------------------------------------------------------------
                                                                                           Wages: No effect
                                                                                           Growth: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 20896]]

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 23) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

IX. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this proposed rule and of possible alternative actions. In doing so, 
the Agency focused on the environmental impacts of its action as a 
result of disposal of unused ESDs that will need to be handled after 
the effective date of the final rule.
    The environmental assessment (EA) considered each of the 
alternatives in terms of the need to provide maximum reasonable 
protection of human health without resulting in a significant impact on 
the environment. The EA considered environmental impacts related to 
landfill and incineration of solid waste at municipal solid waste (MSW) 
facilities. The proposed action will result in an initial batch 
disposal of used and unused ESDs primarily at a single geographic and 
affiliated locations followed by a gradual, intermittent disposal of a 
small number of remaining devices in this and other affected 
communities where these devices are used. The total number of devices 
to be disposed is small, i.e., approximately less than 300 units. 
Overall, given the limited number of ESDs in commerce, the proposed 
action is expected to have no significant impact on MSW and landfill 
facilities and the environment in affected communities.
    The Agency has concluded that the proposed rule will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact (FONSI) and the evidence supporting that finding, contained in 
an EA prepared under 21 CFR 25.40, may be seen in the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday; they are also available electronically at https://www.regulations.gov. FDA invites comments and submission of data 
concerning the EA and FONSI.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires Agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain State requirements ``different from or 
in addition to'' certain Federal requirements applicable to devices 
(see section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr, 
518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). 
If this proposed rule is made final, it would create a Federal 
requirement under section 521 of the FD&C Act that bans ESDs for SIB or 
AB.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XIII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.

    *1. FDA, ``Meeting Materials of the Neurological Devices 
Panel.'' April 24, 2014. Available at: https://wayback.archive-it.org/7993/20170405192749/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm394252.htm.
    2. Bottema-Beutel, K., S. Crowley, M. Sandbank, et al. ``Adverse 
Event Reporting in Intervention Research for Young Autistic 
Children.'' Autism, 25:322-335, 2021. Available at: https://doi.org/10.1177/1362361320965331.
    3. Blenkush, N.A. ``A Risk-Benefit Analysis of Antipsychotic 
Medication and Contingent Skin Shock for the Treatment of 
Destructive Behaviors.'' International Journal of Psychology & 
Behavior Analysis, 3(121):1-14, 2017. Available at: https://doi.org/10.15344/2455-3867/2017/121.
    4. Schuck, R.K., D.M. Tagavi, K.M.P. Baiden, et al. 
``Neurodiversity and Autism Intervention: Reconciling Perspectives 
Through a Naturalistic Developmental Behavioral Intervention 
Framework.'' Journal of Autism and Developmental Disorders, 
52(10):4625-4645, October 13, 2021. Available at: https://doi.org/10.1007/s10803-021-05316-x.
    5. Zarcone, J.R., M.P. Mullane, P.E. Langdon, et al. 
``Contingent Electric Shock as a Treatment for Challenging Behavior 
for People With Intellectual and Developmental Disabilities: Support 
for the IASSIDD Policy Statement Opposing Its Use.'' Journal of 
Policy and Practice in Intellectual Disabilities, 17(4):291-296, 
2020. Available at: https://doi.org/10.1111/jppi.12342.
    6. Mercer, J. ``Evidence of Potentially Harmful Psychological 
Treatments for Children and Adolescents.'' Child and Adolescent 
Social Work Journal, 34(2):107-125, 2017. Available at: https://doi.org/10.1007/s10560-016-0480-2.
    7. Perone, M., D.C. Lerman, S.M. Peterson, et al. ``Report of 
the ABAI Task Force on Contingent Electric Skin Shock.'' 
Perspectives on Behavior Science, 46(2):261-304, 2023. Available at: 
https://doi.org/10.1007/s40614-023-00379-w.
    8. Yadollahikhales, G., N. Blenkush, and M. Cunningham. 
``Response Patterns for Individuals Receiving Contingent Skin Shock 
Aversion Intervention To Treat Violent Self-Injurious and Assaultive 
Behaviours.'' BMJ Case Reports CP, 14(5):e241204, 2021. Available 
at: https://dx.doi.org/10.1136/bcr-2020-241204.
    9. Blenkush, N.A. and J. O'Neill. ``Contingent Skin-Shock 
Treatment in 173 Cases of Severe Problem Behavior.'' International 
Journal of Psychology & Behavior Analysis, 6:167, 2020. Available 
at: https://doi.org/10.15344/2455-3867/2020/167.
    10. O'Neill, J. and N. Blenkush. ``Contingent Skin-Shock 
Treatment and the Reversal of Effects on Severe Problem Behavior.'' 
International Journal of Psychology & Behavior Analysis, 6:168, 
2020. Available at: https://doi.org/10.15344/2455-3867/2020/168.
    11. Blenkush, N. and M. Cunningham. ``Elimination of Refractory 
Aggression and

[[Page 20897]]

Self-Injury With Contingent Skin Shock.'' The Journal of 
Neuropsychiatry and Clinical Neurosciences, 35:264-268, 2023. 
Available at: https://doi.org/10.1176/appi.neuropsych.21020049.
    12. Salerno, J. ``Efficacy, Risks, and Ethics of Aversive or 
Positive Therapy in Identical Twins.'' Ph.D. diss., Walden 
University, 2019. Available at: https://scholarworks.waldenu.edu/dissertations/6946.
    13. Dawson, M. and S. Fletcher-Watson. ``When Autism Researchers 
Disregard Harms: A Commentary.'' Autism, 26(2):564-566, 2022. 
Available at: https://doi.org/10.1177/13623613211031403.
    14. Foxx, R.M. ``The National Institutes of Health Consensus 
Development Conference on the Treatment of Destructive Behaviors: A 
25-Year Update of a Study in Hardball Politics.'' In: Controversial 
Therapies for Autism and Intellectual Disabilities (Second ed.). New 
York, NY: Routledge; part VI, chapter 27, pp. 451-471, 2016. Foxx, 
R.M. and J.A. Mulick (Eds.) Available at: https://www.routledge.com/Controversial-Therapies-for-Autism-and-Intellectual-Disabilities-Fad-Fashion/Foxx-Mulick/p/book/9781138802230.
    15. Leaf, J.B., J.H. Cihon, R. Leaf, et al. ``Concerns About 
ABA-Based Intervention: An Evaluation and Recommendations.'' Journal 
of Autism and Developmental Disorders, 52(6):2838-2853, 2022. 
Available at: https://doi.org/10.1007/s10803-021-05137-y.
    16. Shkedy, G., D. Shkedy, and A.H. Sandoval-Norton. ``Treating 
Self-Injurious Behaviors in Autism Spectrum Disorder.'' Cogent 
Psychology, 6(1):1682766, 2019. Available at: https://doi.org/10.1080/23311908.2019.1682766.
    17. Benevides T.W., S.M. Shore, K. Palmer, et al. ``Listening to 
the autistic voice: Mental health priorities to guide research and 
practice in autism from a stakeholder-driven project.'' Autism, 
24(4):822-833, 2020. Available at https://doi.org/10.1177/1362361320908410.
    18. Yadollahikhales, G., M. Cunningham, and N. Blenkush. 
``Graduated Electrical Decelerator Effectiveness for Severe 
Dangerous Behaviors in Autistic Children: Case Study.'' The Journal 
of Neuropsychology and Clinical Neurosciences, 31(3): E28-E28, 2019. 
Available at https://doi.org/10.1176/appi.neuropsych.18100235.
    19. Lowther, N. and M. Newman. ``Does the Behavioral Progress 
Made at JRC Generalize Across Settings and Over Time? A Follow-Up 
Study of Former JRC Students.'' ABA, 2014.
    20. M[uuml]ller M.J. ``Helplessness and Perceived Pain 
Intensity: Relations to Cortisol Concentrations After 
Electrocutaneous Stimulation in Healthy Young Men.'' BioPsychoSocial 
Medicine, 5:1-7, 2011. Available at https://pubmed.ncbi.nlm.nih.gov/21718526/.
    21. Association for Behavior Analysis International. ``Position 
Statement on the Use of CESS.'' 2022. Available at https://www.abainternational.org/about-us/policies-and-positions/position-statement-on-the-use-of-cess-2022.aspx. (Accessed August 18, 2023.)
    *22. JRC, Inc., public docket comment to the 2016 Proposed Rule, 
tracking number 1k0-8ref-d5le. Received July 25, 2016. Available at: 
https://www.regulations.gov/comment/FDA-2016-N-1111-1637.
    *23. ``Preliminary Regulatory Impact Analysis, Initial 
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act 
Analysis; Banned Devices; Proposal To Ban Electrical Stimulation 
Devices for Self-Injurious or Aggressive Behavior''. Available at: 
https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

List of Subjects

21 CFR Part 882

    Medical devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR parts 882 and 895 be amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec.  882.5235, revise paragraph (b) to read as follows:


Sec.  882.5235  Aversive conditioning device.

* * * * *
    (b) Classification. Class II (special controls), except for 
electrical stimulation devices for self-injurious or aggressive 
behavior. Electrical stimulation devices for self-injurious or 
aggressive behavior are banned. See Sec.  895.105 of this chapter.

PART 895--BANNED DEVICES

0
3. The authority citation for part 895 continues to read as follows:

    Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.

0
4. Add Sec.  895.105 to subpart B to read as follows:


Sec.  895.105  Electrical stimulation devices for self-injurious or 
aggressive behavior.

    Electrical stimulation devices for self-injurious or aggressive 
behavior are aversive conditioning devices that apply a noxious 
electrical stimulus to a person's skin to reduce or cease self-
injurious or aggressive behavior.

    Dated: March 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-06037 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P