Notice2021-18592
Safety and Performance Based Pathway Device-Specific Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
August 30, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathway--specifically, ``Denture Base Resins--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff'' and ``Facet Screw Systems--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidance documents are not final nor are they in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 165 (Monday, August 30, 2021)</title>
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[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48430-48431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-D-0603 and FDA-2021-D-0604]
Safety and Performance Based Pathway Device-Specific Guidances;
Draft Guidances for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of two draft device-specific guidance documents for
the Safety and Performance Based Pathway--specifically, ``Denture Base
Resins--Performance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff''
and ``Facet Screw Systems--Performance Criteria for Safety and
Performance Based Pathway; Draft Guidance for Industry and Food and
Drug Administration Staff.'' The device-specific guidances identified
in this notice were developed in accordance with the finalized guidance
entitled ``Safety and Performance Based Pathway.'' These draft guidance
documents are not final nor are they in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by October 29, 2021 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-D-0603 for ``Denture Base Resins--Performance Criteria for
Safety and Performance Based Pathway; Draft Guidance for Industry and
Food and Drug Administration Staff'' and Docket No. FDA-2021-D-0604 for
``Facet Screw Systems--Performance Criteria for Safety and Performance
Based Pathway; Draft Guidance for Industry and Food and Drug
Administration Staff.'' Received comments will be placed in the dockets
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
``Denture Base Resins--Performance Criteria for Safety and Performance
Based Pathway; Draft Guidance for Industry and Food and Drug
Administration Staff'' or ``Facet Screw Systems--Performance Criteria
for Safety and Performance Based Pathway; Draft Guidance for Industry
and Food and Drug Administration Staff'' 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: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
[[Page 48431]]
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.
SUPPLEMENTARY INFORMATION:
I. Background
These draft device-specific guidance documents provide performance
criteria for premarket notification (510(k)) submissions to support the
optional Safety and Performance Based Pathway, as described in the
guidance entitled ``Safety and Performance Based Pathway.'' As
described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices. However, the
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under this optional Safety and Performance Based
Pathway, a submitter could satisfy the requirement to compare its
device with a legally marketed device by, among other things,
independently demonstrating that the device's performance meets
performance criteria as established in the above-listed guidance
documents, when finalized, rather than using direct predicate
comparison testing for some of the performance characteristics.
These draft guidance documents are being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). These draft
guidance documents, when finalized, will represent the current thinking
of FDA on performance criteria for the Safety and Performance Based
Pathway for ``Denture Base Resins'' and ``Facet Screw Systems.'' They
do not establish any rights for any person and are 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. These guidance documents are
also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Persons unable to download an electronic copy of ``Denture Base
Resins--Performance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff
(document number 20001)'' or ``Facet Screw Systems--Performance
Criteria for Safety and Performance Based Pathway; Draft Guidance for
Industry and Food and Drug Administration Staff (document number
21001)'' may send an email request to <a href="/cdn-cgi/l/email-protection#dd9e998f95f09aa8b4b9bcb3beb89dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="9dded9cfd5b0dae8f4f9fcf3fef8ddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a> to
receive an electronic copy of the document. Please use the document
number and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidance documents contain no new collection of
information, they do 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 regulation and
guidance have been approved by OMB as listed in the following table:
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OMB control
21 CFR part; guidance; or FDA form Topic No.
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807, subpart E.................... Premarket 0910-0120
notification.
``Requests for Feedback and Q-submissions; Pre- 0910-0756
Meetings for Medical Device submissions.
Submissions: The Q-Submission
Program''.
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Dated: August 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18592 Filed 8-27-21; 8:45 am]
BILLING CODE 4164-01-P
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