[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65410-65412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22876]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0350]
Select Updates for Biocompatibility of Certain Devices in Contact
With Intact Skin; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Select Updates for
Biocompatibility of Certain Devices in Contact with Intact Skin.'' FDA
has developed this draft guidance to propose select updates to FDA's
current thinking regarding the type of biocompatibility information
that should be provided in a premarket submission for certain devices
made from common polymers and fabrics that are in contact with intact
skin. This draft guidance is not final nor is it in effect at this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DATES: Submit either electronic or written comments on the draft
guidance by December 14, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
[[Page 65411]]
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-2013-D-0350 for ``Select Updates for Biocompatibility of Certain
Devices in Contact with Intact Skin.'' 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.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 draft guidance document entitled
``Select Updates for Biocompatibility of Certain Devices in Contact
with Intact Skin'' to the Office of Policy, 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: Jennifer Goode, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-796-5701.
SUPPLEMENTARY INFORMATION:
I. Background
Many devices have intact skin contacting component materials that
are made from polymers and fabrics. FDA believes these materials pose a
very low biocompatibility risk because they have a long history of safe
use in medical devices that contact intact skin. For such devices,
significant FDA review resources are expended to obtain sufficient
rationales to justify omission of biocompatibility testing for
frequently used intact skin contacting medical devices, consistent with
FDA's recommendations in the FDA guidance ``Use of International
Standard ISO 10993-1, `Biological evaluation of Medical Devices--Part
1: Evaluation and testing within a risk management process' '' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and).
This select update describes a least burdensome approach for these
devices that recommends specific material information in a premarket
submission in lieu of biocompatibility testing. This approach also
supports the principles of the ``3Rs,'' to reduce, refine, and replace
animal use in testing when feasible. This approach is partially based
on FDA's experience with these common polymers and fabrics. This
approach also relies on certain parts of the Quality System Regulation
(21 CFR part 820) and other postmarket controls that already require
compliance (e.g., 21 CFR part 803) to identify potential
biocompatibility-related issues.
After FDA finalizes this guidance, FDA intends to periodically
reassess the list of component materials and exclusion characteristics
identified in this guidance. FDA requests that external stakeholders
submit comments to the docket to suggest the addition or removal of
component materials or exclusion characteristics from this policy,
including a rationale. FDA intends to review comments received in the
docket and periodically assess whether any changes to this policy are
warranted. When FDA believes changes are warranted, FDA will issue
updated guidance in accordance with the procedures in the Good Guidance
Practices Regulation (21 CFR 10.115).
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 ``Select
Updates for Biocompatibility of Certain Devices in Contact with Intact
Skin.'' 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 draft 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. Persons unable to download an
electronic copy of ``Select Updates for Biocompatibility of Certain
Devices in Contact with Intact
[[Page 65412]]
Skin'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 19007 to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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OMB control
21 CFR part or guidance Topic No.
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807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Device 0910-0332
Exemption.
812............................ Investigational Device 0910-0078
Exemption.
``De Novo Classification De Novo classification 0910-0844
Process (Evaluation of process.
Automatic Class III
Designation)``.
``Requests for Feedback on Q-submissions.......... 0910-0756
Medical Device Submissions:
The Pre-Submission Program and
Meetings with Food and Drug
Administration Staff``.
800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
803............................ Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor reporting.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
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Dated: October 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22876 Filed 10-14-20; 8:45 am]
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