Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Non-Clinical Testing and Clinical Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability, 27443-27444 [2021-10622]

Download as PDF Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices Dated: May 14, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10592 Filed 5–19–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1130] Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation—Non-Clinical Testing and Clinical Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Implanted BrainComputer Interface (BCI) Devices for Patients with Paralysis or Amputation— Non-Clinical Testing and Clinical Considerations.’’ Implanted braincomputer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies. DATES: The announcement of the guidance is published in the Federal Register on May 20, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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 VerDate Sep<11>2014 17:36 May 19, 2021 Jkt 253001 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– 2014–N–1130 for ‘‘Implanted BrainComputer Interface(BCI) Devices for Patients with Paralysis or Amputation— Non-clinical Testing and Clinical Considerations.’’ Received comments 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 must identify this information as PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 27443 ‘‘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-201509-18/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Implanted BrainComputer Interface (BCI) Devices for Patients with Paralysis or Amputation— Non-clinical Testing and Clinical Considerations’’ to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4108, Silver Spring, MD 20993–0002, 301–796–6610. SUPPLEMENTARY INFORMATION: I. Background The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life. On November 21, 2014, the Center for Devices and Radiological Health (CDRH) held an open public workshop with the aim of fostering an open discussion on the scientific and clinical considerations associated with the E:\FR\FM\20MYN1.SGM 20MYN1 27444 Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices development of implanted BCI devices. FDA considered the input provided during this workshop to develop this guidance document. This guidance document provides clinical study design and nonclinical testing recommendations associated with BCI devices. This is a leapfrog guidance: A type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leapfrog guidance represents the Agency’s initial thinking and our recommendations may change as more information becomes available. A notice of availability of the draft guidance appeared in the Federal Register of February 25, 2019 (84 FR 6007). FDA considered comments received and revised the guidance as appropriate in response to the comments, including the addition of a brief section on Human Factors recommending that usability information be captured early in device development and continue iteratively, and a recommendation in the ‘‘Home Use’’ section, to describe the training related to home use of the devices and how the effectiveness of this training will be evaluated. A clarification was also added in the Scope section to highlight that for any BCI devices with technological characteristics, components, or indications for use or patient population not described in the guidance, manufacturers/investigators should submit a pre-submission to seek FDA feedback. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Implanted BrainComputer Interface (BCI) Devices for Patients with Paralysis or Amputation— Non-Clinical Testing and Clinical Considerations.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidance- documents-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download an electronic copy of ‘‘Implanted BrainComputer Interface (BCI) Devices for Patients with Paralysis or Amputation— Non-clinical Testing and Clinical Considerations ’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500045 to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: OMB control No. 21 CFR part or guidance Topic 812 .............................................................................................. ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’. 801 .............................................................................................. 820 .............................................................................................. Investigational Device Exemption .............................................. Q-submissions ............................................................................ 0910–0078 0910–0756 Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Protection of Human Subjects: Informed Consent; Institutional Review Boards. 0910–0485 0910–0073 50, 56 .......................................................................................... Dated: May 14, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–10622 Filed 5–19–21; 8:45 am] [Docket No. FDA–2019–D–2837] BILLING CODE 4164–01–P Food and Drug Administration Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ‘‘Testing and Labeling Medical Devices for Safety in the SUMMARY: VerDate Sep<11>2014 17:36 May 19, 2021 Jkt 253001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 0910–0755 Magnetic Resonance (MR) Environment.’’ FDA developed this guidance to provide FDA’s recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices. The announcement of the guidance is published in the Federal Register on May 20, 2021. DATES: You may submit either electronic or written comments on ADDRESSES: E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27443-27444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10622]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1130]


Implanted Brain-Computer Interface Devices for Patients With 
Paralysis or Amputation--Non-Clinical Testing and Clinical 
Considerations; Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Implanted Brain-
Computer Interface (BCI) Devices for Patients with Paralysis or 
Amputation--Non-Clinical Testing and Clinical Considerations.'' 
Implanted brain-computer interface (BCI) devices are neuroprostheses 
that interface with the central or peripheral nervous system to restore 
lost motor and/or sensory capabilities in patients with paralysis or 
amputation. This guidance provides recommendations for nonclinical 
testing and study design considerations for investigational device 
exemptions feasibility and pivotal clinical studies.

DATES: The announcement of the guidance is published in the Federal 
Register on May 20, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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-2014-N-1130 for ``Implanted Brain-Computer Interface(BCI) Devices 
for Patients with Paralysis or Amputation--Non-clinical Testing and 
Clinical Considerations.'' Received comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Implanted Brain-Computer Interface (BCI) Devices for Patients with 
Paralysis or Amputation--Non-clinical Testing and Clinical 
Considerations'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4108, Silver Spring, MD 20993-0002, 301-796-6610.

SUPPLEMENTARY INFORMATION: 

I. Background

    The field of implanted BCI devices is progressing rapidly from 
fundamental neuroscience discoveries to translational applications and 
market access. Implanted BCI devices have the potential to bring 
benefit to people with severe disabilities by increasing their ability 
to interact with their environment, and consequently, providing new 
independence in daily life. On November 21, 2014, the Center for 
Devices and Radiological Health (CDRH) held an open public workshop 
with the aim of fostering an open discussion on the scientific and 
clinical considerations associated with the

[[Page 27444]]

development of implanted BCI devices. FDA considered the input provided 
during this workshop to develop this guidance document. This guidance 
document provides clinical study design and nonclinical testing 
recommendations associated with BCI devices.
    This is a leapfrog guidance: A type of guidance that serves as a 
mechanism by which the Agency can share initial thoughts regarding 
emerging technologies that are likely to be of public health importance 
early in product development. This leapfrog guidance represents the 
Agency's initial thinking and our recommendations may change as more 
information becomes available.
    A notice of availability of the draft guidance appeared in the 
Federal Register of February 25, 2019 (84 FR 6007). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including the addition of a brief section on Human 
Factors recommending that usability information be captured early in 
device development and continue iteratively, and a recommendation in 
the ``Home Use'' section, to describe the training related to home use 
of the devices and how the effectiveness of this training will be 
evaluated. A clarification was also added in the Scope section to 
highlight that for any BCI devices with technological characteristics, 
components, or indications for use or patient population not described 
in the guidance, manufacturers/investigators should submit a pre-
submission to seek FDA feedback.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Implanted Brain-Computer Interface (BCI) 
Devices for Patients with Paralysis or Amputation--Non-Clinical Testing 
and Clinical Considerations.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Implanted Brain-Computer Interface 
(BCI) Devices for Patients with Paralysis or Amputation--Non-clinical 
Testing and Clinical Considerations '' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1500045 to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidance have been 
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
812...............................  Investigational            0910-0078
                                     Device Exemption.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Q-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
801...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
------------------------------------------------------------------------


    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10622 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P
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