Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures, 71191-71196 [2021-27137]

Agencies

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

[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Proposed Rules]
[Pages 71191-71196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27137]



[[Page 71191]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2021-N-0310]
RIN 0910-AI32


Medical Devices; Orthopedic Devices; Classification of Spinal 
Spheres for Use in Intervertebral Fusion Procedures

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to classify spinal spheres for use in intervertebral fusion procedures 
(an unclassified, preamendments device) into class III for which FDA is 
separately proposing to require the filing of a premarket approval 
application (PMA). FDA has determined that general controls and special 
controls together are insufficient to provide reasonable assurance of 
safety and effectiveness for this device. FDA is publishing this 
proposed rule based, in part, on the recommendations of the Orthopaedic 
and Rehabilitation Devices Panel, regarding the classification of 
spinal spheres for use in intervertebral fusion procedures.

DATES: Submit either electronic or written comments on the proposed 
rule by March 15, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 15, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 15, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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-2021-N-0310 for ``Medical Devices; Orthopedic Devices; 
Classification of Spinal Spheres for Use in Intervertebral Fusion 
Procedures.'' 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 office 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 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 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: Constance Soves, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-
796-6951, [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. Need for the Regulation
    B. FDA's Current Regulatory Framework
    C. History of This Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
    A. Device Description
    B. Risks to Health and Public Health Benefits
    C. Proposed Classification and FDA's Findings
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

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I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to classify spinal spheres for use in 
intervertebral fusion procedures (spinal spheres), which are 
unclassified, preamendments devices, into class III. A spinal sphere is 
a prescription device used to provide stabilization of a spinal segment 
as an adjunct to fusion. FDA currently regulates these unclassified 
devices as devices requiring premarket notification, with the product 
code NVR.
    FDA initiated the classification of spinal spheres by consulting 
the Orthopaedic and Rehabilitation Devices Panel (the Panel). The Panel 
recommended that spinal spheres be classified into class III because 
there was a lack of available evidence to determine that general and 
special controls are sufficient to provide reasonable assurance of its 
safety and effectiveness, and these devices present a potential 
unreasonable risk of illness or injury. FDA conducted its own analysis 
as described below and agrees with the Panel's recommendation. As such, 
FDA proposes to classify spinal spheres into class III. FDA is also 
proposing, by proposed order published elsewhere in this issue of the 
Federal Register, to require the filing of PMAs for such devices.

B. Summary of the Major Provisions of the Proposed Rule

    This rule proposes to classify spinal spheres into class III. The 
proposed rule, if finalized, would establish the identification and 
classification for spinal spheres. In addition, FDA proposes that the 
use of spinal spheres devices be limited to prescription use.

C. Legal Authority

    The Agency is proposing this classification under the authority of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301). 
Specifically, the relevant authority related to the proposed 
classification includes section 513(a) through (d) of the FD&C Act (21 
U.S.C. 360c(a) through (d)), regarding device classes, classification, 
and panels, and section 515 (21 U.S.C. 360e), regarding PMAs.

D. Costs and Benefits

    This proposed rule, if finalized, would classify spinal spheres for 
use in intervertebral fusion procedures (an unclassified, preamendments 
device) into class III for which FDA is separately proposing to require 
the filing of a premarket approval application. The costs of the rule 
include one-time costs associated with reading the proposed rule. FDA 
is only able to identify the costs of this proposed rule. We estimate 
that the present value of the costs of the rule are between $427 and 
$20,480, with a primary estimate of $10,453. Annualizing over a 10-year 
period at a discount rate of 3 percent, the costs of this proposed rule 
are estimated to be between $29 and $1,377, with a primary estimate of 
$703. Annualizing over a 10-year period at a discount rate of 7 
percent, the costs of this proposed rule are estimated to be between 
$40 and $1,933, with a primary estimate of $987.

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

                                                           Table 1--Abbreviations and Acronyms
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          Abbreviation or acronym                                                           What it means
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k).....................................  Premarket Notification.
CoCrMo.....................................  cobalt-chromium-molybdenum.
FDA........................................  Food and Drug Administration.
FD&C Act...................................  Federal Food, Drug, and Cosmetic Act.
MAUDE......................................  FDA's Manufacturer and User Facility Device Experience database.
OMB........................................  Office of Management and Budget.
PMA........................................  Premarket Approval Application.
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III. Background

A. Need for the Regulation

    Currently, spinal spheres are unclassified devices subject to 
premarket notification (510(k)) under section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)). Until an unclassified device type has been formally 
classified by regulation, marketing of new devices within this device 
type requires FDA clearance of a 510(k). As described below, FDA 
granted the first clearance for spinal spheres (K051320, September 9, 
2005) based on documentation that demonstrated that these devices were 
substantially equivalent to devices that were in commercial 
distribution prior to passage of the Medical Device Amendments on May 
28, 1976. Because the clinical evidence is limited, FDA is proposing to 
classify spinal spheres into class III, subject to PMA.

B. FDA's Current Regulatory Framework

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical 
Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the FD&C Act established 
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).
    Section 513(a)(1) of the FD&C Act defines the three classes of 
devices. Class I devices are those devices for which the general 
controls of the FD&C Act (controls authorized by or under sections 501, 
502, 510, 516, 518, 519, or 520 of the FD&C Act (21 U.S.C. 351, 352, 
360, 360f, 360h, 360i, or 360j) or any combination of such sections) 
are sufficient to provide reasonable assurance of safety and 
effectiveness; or those devices for which insufficient information 
exists to determine that general controls are sufficient to provide 
reasonable assurance of safety and effectiveness or to establish 
special controls to provide such assurance, but because the devices are 
not purported or represented to be for a use in supporting or 
sustaining human life or for a use which is of substantial importance 
in preventing impairment of human health, and do not present a 
potential unreasonable risk of illness or injury, are to be regulated 
by general controls (section 513(a)(1)(A) of the FD&C Act). 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

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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). Class III devices are those devices for which insufficient 
information exists to determine that general controls (controls 
authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 of 
the FD&C Act or any combination of such sections) and special controls 
would provide a reasonable assurance of safety and effectiveness, and 
are purported or represented for a use in supporting or sustaining 
human life or for a use which is of substantial importance in 
preventing impairment of human health, or present a potential 
unreasonable risk of illness or injury (section 513(a)(1)(C) of the 
FD&C Act).
    Under section 513(d) of the FD&C Act, FDA refers to devices that 
were in commercial distribution before the 1976 amendments as 
``preamendments devices.'' FDA classifies these devices after the 
Agency: (1) Receives a recommendation from a device classification 
panel (an FDA advisory committee); (2) publishes the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) publishes a final regulation 
classifying the device (section 513(d)(1) of the FD&C Act). FDA has 
classified most preamendments devices under these procedures.
    A person may market a preamendments device that has been classified 
into class III through premarket notification procedures without 
submission of a PMA until FDA issues a final regulation order under 
section 515(b) of the FD&C Act requiring premarket approval. FDA is 
also proposing, by proposed order published elsewhere in this issue of 
the Federal Register, to require the filing of PMAs for such devices.
    After the enactment of the 1976 amendments, FDA undertook an effort 
to identify and classify all preamendments devices in accordance with 
section 513(d) of the FD&C Act. As part of this effort, FDA issued a 
proposed rule for classification of 77 generic types of orthopedic 
devices in the Federal Register of September 4, 1987 (52 FR 33686). 
However, spinal spheres were not included in this action and were never 
separately classified. FDA initiated the classification of spinal 
spheres by holding a panel meeting on December 12, 2013, regarding the 
classification of spinal spheres (Ref. 1).

C. History of This Rulemaking

    As described previously, spinal spheres for use in intervertebral 
fusion procedures are unclassified, preamendments devices. These 
devices have been subject to premarket review through a 510(k) 
submission and have been cleared for marketing if FDA considers the 
device to be substantially equivalent to a legally marketed predicate 
in accordance with section 513(i) of the FD&C Act. To date, FDA has 
cleared six spinal sphere devices from four manufacturers. Spinal 
sphere devices, however, are no longer used due to the widespread 
adoption of intervertebral body fusion devices (``interbody cages''). 
Unlike spinal sphere devices, interbody cages generally possess 
different features to engage with vertebral endplates, allowing them to 
resist migration and subsidence, and features that allow for the 
packing of graft material, facilitating bone growth into and through 
the device.
    On December 12, 2013, FDA convened the Panel to secure 
recommendations regarding the appropriate classification, regulatory 
controls, as well as risks to health and benefits of spinal spheres 
(Ref. 1). At the meeting, FDA requested the Panel consider whether this 
device type fits the statutory definition for a class III device. The 
Panel considered the information provided by FDA about spinal spheres, 
including results and analysis from a literature search and search of 
known adverse events (Ref. 1).
    The Panel unanimously recommended that spinal spheres be classified 
into class III, subject to PMA. The Panel believed that classification 
in class III is appropriate given that there was a lack of available 
evidence to determine that general and special controls are sufficient 
to provide reasonable assurance of its safety and effectiveness for use 
in intervertebral body fusion procedures. Furthermore, the Panel 
unanimously agreed that spinal spheres for use in fusion procedures 
present an unreasonable risk of illness or injury to the patients. In 
addition to the risks to health identified by FDA that include removal/
revision, pain, and neurologic impairment, the Panel recommended 
incorporating all known risks generally associated with spinal 
interbody fusion procedures (see Ref. 1, Panel transcript at page 58). 
In summary, the Panel unanimously determined that given the lack of 
available evidence and unreasonable risk profile of spinal spheres 
devices for use in fusion procedures, these devices should be 
classified as class III devices which would, after publication of a 
final order calling for PMAs, require submission of a PMA and approval 
to market the device. FDA agrees with the Panel's recommendation that 
there was a lack of available evidence to determine that general and 
special controls are sufficient to provide reasonable assurance of its 
safety and effectiveness, and that the device presents a potential 
unreasonable risk of illness or injury. FDA further agrees with the 
Panel's recommendation that spinal sphere devices for use in fusion 
procedures be classified into class III subject to PMA.

IV. Legal Authority

    The Agency is proposing this classification under the authority of 
the FD&C Act (21 U.S.C. 301). Specifically, the relevant authority 
related to the proposed classification includes sections 513(a) through 
(d), regarding device classes, classification, and panels; and section 
515, regarding PMAs.

V. Description of the Proposed Rule

    We are proposing to amend subpart D of 21 CFR part 888 by adding 
Sec.  888.3085 to classify spinal spheres for use in intervertebral 
fusion procedures in accordance with section 513(d) of the FD&C Act. 
This proposed rule applies to spinal spheres for use in intervertebral 
fusion procedures regulated under the product code NVR. This proposed 
rule does not apply to spinal spheres intended for use in non-fusion 
procedures, which are currently regulated as class III devices subject 
to PMA requirements.

A. Device Description

    A spinal sphere for use in intervertebral fusion procedures is a 
prescription device that is an implanted, solid, spherical device 
manufactured from metallic (e.g., cobalt-chromium-molybdenum (CoCrMo)) 
or polymeric (e.g., polyetheretherketone) materials. They are intended 
to be inserted into the intervertebral disc space of the lumbar spine 
following a discectomy in order to maintain disc space height and 
provide postoperative stabilization to the affected spinal segment 
during fusion procedures. The device is to be used with bone graft 
material. FDA currently regulates these unclassified devices as devices 
requiring a 510(k) submission under product code NVR.

B. Risks to Health and Public Health Benefits

    In evaluating the risks to health associated with use of spinal 
spheres, FDA considered information from the

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2013 Orthopaedic and Rehabilitation Panel meeting, the adverse event 
reports for spinal spheres in FDA's Manufacturer and User Facility 
Device Experience (MAUDE) database, and published scientific 
literature, which is discussed in FDA's executive summary for the Panel 
meeting (Ref. 1). We also considered adverse event reports and 
literature since that time, which is consistent with the prior 
information that was analyzed for the Panel meeting.
    FDA's review of the information in the MAUDE database, as presented 
to the Panel, resulted in the identification of 21 unique Medical 
Device Reports (MDRs) on spinal sphere devices. Of this total, 18 MDRs 
were reported as injuries and 3 as malfunctions. Three additional MDRs 
have been reported under this product code since the previous review of 
the MAUDE database prior to the Panel meeting. One report reflects use 
of a spinal sphere device without fusion that was also reported in the 
literature as discussed below. One report was regarding devices that 
were not spinal spheres, and the remaining report was unclear on the 
device that caused the event.
    Additionally, for the purposes of the Panel, FDA conducted a 
comprehensive literature review to identify and gather relevant 
published information regarding the safety and effectiveness of spinal 
sphere devices for use in fusion procedures. However, no references 
specifically describing spinal sphere devices for use in fusion 
procedures were identified. A contemporary search using the same 
parameters yielded a similar result. Of note, one article, a case study 
of a patient implanted with a spinal sphere, reflected one of the MDRs 
reported above; however, this patient did not undergo spinal fusion in 
conjunction with implantation of the device (Ref. 2). Consequently, FDA 
concludes there is inadequate information characterizing the safety and 
effectiveness of spinal sphere devices when used for fusion procedures. 
The 510(k) clearances of these devices were based solely on nonclinical 
information and determinations of substantial equivalence to the 
preamendments device in accordance with section 513(i) of the FD&C Act, 
which, in light of the available information regarding the risks with 
no information supporting the benefit of these devices, is inadequate 
to support a reasonable assurance of safety and effectiveness for these 
devices.
    At the Panel, FDA identified the following risks to health 
associated with spinal spheres that could result from device-related 
adverse events, including implant breakage during implantation, device 
migration and/or subsidence, removal/revision, pain, and neurological 
impairment. The Panel agreed with the risks to health and emphasized 
that there would likely be a significantly higher risk of revision or 
clinical failure as compared to standard intervertebral body fusion 
devices. Furthermore, the Panel noted that these risks to health may 
arise from mechanical instability associated with placement of a 
spherical implant inserted between the parallel vertebral endplates. 
Additionally, the Panel acknowledged that the risks to health 
identified for intervertebral body fusion devices would also apply to 
spinal spheres (Ref. 1). These devices are similar in terms of 
materials, placement, and insertion, and therefore spheres would also 
carry similar risks as those already identified for intervertebral body 
fusion devices. The risks to health associated with use of 
intervertebral body fusion devices that contain bone grafting material 
identified during their reclassification were infection, adverse tissue 
reaction, pain and loss of function, soft tissue injury, vertebral 
endplate injury, reoperation, and pseudarthrosis (i.e., non-union) (72 
FR 32170, June 12, 2007).
    FDA agrees with the Panel's recommendations to incorporate the 
risks to health associated with intervertebral body fusion devices into 
the list of risks to health FDA identified as associated with spinal 
spheres to more completely capture the risks to health associated with 
such devices. FDA notes that the risk of vertebral endplate injury as 
described in the risks associated with intervertebral body fusion 
devices also encompasses the risk of subsidence; therefore, we are not 
listing subsidence as a unique risk to health for spinal spheres. Based 
on this information, FDA has identified and proposes the following 
risks to health for spinal spheres:
    (1) Reoperation: The need for reoperation could result from a 
failed spinal sphere device or component of the device, from nerve root 
decompression or adjacent level disease, or from reasons related to any 
surgery, e.g., infection or bleeding.
    (2) Pain and loss of function: Some device-related complications 
that may cause pain and loss of function include device fracture, 
deformation, loosening, or extrusion. The wear of materials, which may 
cause osteolysis (dissolution of bone), and component disassembly, 
fracture, or failure may also result in pain and loss of function.
    (3) Infection: Infection of the soft tissue, bony tissue, and the 
disc space may arise due to implantation of a spinal sphere device. 
Material composition or impurities, wear debris, operative time, and 
operative environment may compromise the vascular supply to the area or 
affect the immune system, which could increase the risk of infection. 
Improper sterilization or packaging may also increase the risk of 
infection.
    (4) Adverse tissue reaction: The implantation of the spinal sphere 
device will elicit a mild inflammatory reaction typical of a normal 
foreign body response. Incompatible materials or impurities in the 
materials and wear debris may increase the severity of a local tissue 
reaction or cause a systemic tissue reaction. If the materials used in 
the manufacture of the spinal sphere device are not biocompatible, the 
patient could have an adverse tissue reaction.
    (5) Soft tissue injury: Soft tissue injury could include injury to 
major blood vessels, viscera, nerve roots, spinal cord, and cauda 
equina.
    (6) Vertebral endplate injury: Surgically inserting a device with a 
different geometry and modulus of elasticity than bone may lead to 
vertebral fracture, sinking of the device into the vertebral endplate 
(subsidence), collapse of the local blood supply, and collapse of the 
vertebral end plate.
    (7) Pseudarthrosis: Pseudarthrosis (i.e., non-union) signifies 
failure of the bony fusion mass and results in persistent instability.
    (8) Implant migration and/or instability: The spinal sphere device 
may not adequately stabilize the disc space and may migrate out of its 
intended placement as it is a spherical implant inserted between the 
parallel vertebral endplates. This may lead to subsequent adverse 
clinical sequelae, such as pain or loss of function or pseudarthrosis.
    (9) Implant breakage during insertion: The device may fracture 
during implantation, which could result in a mechanical or functional 
failure. This may lead to subsequent adverse clinical sequelae, such as 
neurologic, vascular, or osseous injury.
    The purported benefit of use of spinal spheres for use in 
intervertebral fusion procedures is to provide stabilization of a 
spinal segment, as an adjunct to fusion. As described above, however, 
FDA is not aware of evidence supporting the stated benefit of spinal 
spheres for use in fusion procedures.

C. Proposed Classification and FDA's Findings

    Based on FDA's experience with spinal spheres, the Panel's 
recommendations, and other available

[[Page 71195]]

information, FDA is proposing to classify spinal spheres for use in 
intervertebral fusion procedures into class III. FDA is proposing this 
classification because FDA believes that insufficient information 
exists to determine that general controls and special controls would 
provide reasonable assurance of safety and effectiveness for such 
devices and, based upon assessment of benefits and risks, these devices 
present a potential unreasonable risk of illness or injury. Elsewhere 
in this issue of the Federal Register, FDA is proposing through a 
proposed order to require the filing of a PMA under section 515(b) of 
the FD&C Act. The proposed order will only be finalized if and when FDA 
finalizes this proposed rule classifying spinal spheres in class III.

VI. Proposed Effective/Compliance Dates

    FDA proposes that any final rule, based on this proposed rule, 
become effective 30 days after its date of publication in the Federal 
Register.
    If this proposed rule and related proposed order to require the 
filing of a PMA are finalized, spinal spheres for use in intervertebral 
fusion procedures are considered adulterated if a PMA is not filed with 
FDA within 30 months after the classification of the device into class 
III, and commercial distribution of the product must cease (see section 
501(f)(1)(2)(B) of the FD&C Act). However, the product may be 
distributed for investigational use only, if the requirements of the 
investigational device exemptions regulations in 21 CFR part 812 are 
met.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, 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 and 13563 direct us to assess all costs 
and benefits 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). We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the estimated costs imposed on any affected firm are 
very low, 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 an assessment of 
anticipated costs and benefits, 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 current threshold after adjustment 
for inflation is $158 million, using the most current (2020) 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 Costs and Benefits

    This proposed rule, if finalized would classify spinal spheres for 
use in intervertebral fusion procedures (an unclassified, preamendments 
device) into class III for which FDA is separately proposing to require 
the filing of a PMA.
    The costs of the proposed rule are summarized in table 2; we did 
not quantify benefits for this proposed rule. The costs of the rule 
include one-time costs associated with reading the proposed rule. The 
present value of the costs of the rule are estimated to be between $427 
and $20,480, with a primary estimate of $10,453. The annualized value 
of the primary estimate of costs over 10 years at a 3 percent discount 
rate is approximately $703. The annualized value of the primary 
estimate of costs over 10 years at a 7 percent discount rate is 
approximately $987.

                Table 2--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                                 Units
                                                                 ------------------------------------
          Category              Primary       Low        High                  Discount     Period       Notes
                               estimate    estimate    estimate      Year        rate       covered
                                                                    dollars    (percent)    (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Quantified..............  ..........  ..........  ..........  ..........           3          10
    Qualitative.............  ..........  ..........  ..........  ..........  ..........
Costs:
    Annualized..............    $0.00099    $0.00004    $0.00193        2019           7          10
    Monetized $millions/year     0.00070     0.00003     0.00138        2019           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Quantified..............  ..........  ..........  ..........  ..........           3          10
    Qualitative.............  ..........  ..........  ..........  ..........  ..........          10
Transfers:
    Federal.................  ..........  ..........  ..........  ..........           7          10
    Annualized..............  ..........  ..........  ..........  ..........           3          10
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........          10
                             ------------------------------------------------------------------------
    From/To.................                 From:
                                              To:
----------------------------------------------------------------------------------------------------------------
    Other...................  ..........  ..........  ..........  ..........           7          10
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........          10
                             ------------------------------------------------------------------------

[[Page 71196]]

 
    From/To.................                 From:
                                              To:
----------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal
     Government: None.
    Small Business: Costs
     would not exceed 0.002
     percent of average
     small firm annual
     revenues.
    Wages: None.
    Growth: None.
----------------------------------------------------------------------------------------------------------------

    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. 3) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. 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.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XI. 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.

XII. 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. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

    1. * Orthopaedic and Rehabilitation Devices Panel--
Classification of Spinal Sphere Devices Meeting, December 12, 2013, 
available at https://wayback.archive-it.org/7993/20170405192244/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.
    2. Lindley, E.M., B. Levy, E.L. Burger, et al., ``Failure of the 
Fernstrom Ball in Contemporary Spine Surgery: A Case of History 
Repeating Itself.'' Current Orthopaedic Practice, 25(1): 87-91, 
2014.
    3. * FDA's full preliminary analysis of economic impacts is 
available in the Docket No. FDA-2021-N-0310 for this proposed rule 
and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 888

    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 part 888 be amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

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

0
2. Add Sec.  888.3085 to subpart D to read as follows:


Sec.  888.3085  Spinal spheres for use in intervertebral fusion 
procedures.

    (a) Identification. A spinal sphere device is an implanted, solid, 
spherical, prescription device manufactured from metallic or polymeric 
materials. The device is inserted into the intervertebral body space of 
the lumbar spine to provide stabilization and to help promote 
intervertebral body fusion. The device is to be used with bone graft 
material.
    (b) Classification. Class III.

    Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27137 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P