[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6007-6009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03144]
-----------------------------------------------------------------------
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--Nonclinical Testing and Clinical
Considerations; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Implanted Brain-
Computer Interface Devices for Patients with Paralysis or Amputation--
Nonclinical Testing and Clinical
[[Page 6008]]
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 This draft guidance provides
recommendations for nonclinical testing and study design considerations
for investigational device exemptions feasibility and pivotal clinical
studies. This draft guidance is not final nor is it in effect at this
time.
DATES: Submit either electronic or written comments on the draft
guidance by April 26, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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 Devices for
Patients with Paralysis or Amputation--Nonclinical 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.
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.gpo.gov/fdsys/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.
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 draft guidance document entitled
``Implanted Brain-Computer Interface Devices for Patients with
Paralysis or Amputation--Nonclinical Testing and Clinical
Considerations'' to the Office of the Center Director, Guidance and
Policy Development, 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. 2668, Silver Spring, MD 20993-0002, 301-796-1136.
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 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.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on implanted BCI
devices for patients with paralysis or amputation--
[[Page 6009]]
nonclinical 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. This guidance is not subject to
Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available
at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Implanted Brain-Computer Interface Devices for
Patients with Paralysis or Amputation--Nonclinical 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.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). 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 Device 0910-0078
Exemption.
``Requests for Feedback on Q-submissions.......... 0910-0756
Medical Device Submissions:
The Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
801............................ Medical Device Labeling 0910-0485
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: February 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03144 Filed 2-22-19; 8:45 am]
BILLING CODE 4164-01-P