[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21889-21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07934]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0603 and FDA-2021-D-0604]
Performance Criteria for Safety and Performance Based Pathway;
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 two final device-specific guidance documents for
the Safety and Performance Based Pathway--specifically, ``Denture Base
Resins--Performance Criteria for Safety and Performance Based Pathway;
Guidance for Industry and Food and Drug Administration Staff'' and
``Facet Screw Systems--Performance Criteria for Safety and Performance
Based Pathway; Guidance for Industry and Food and Drug Administration
Staff.'' The device-specific guidances identified in this notice were
developed in accordance with the final guidance entitled ``Safety and
Performance Based Pathway.''
DATES: The announcement of the guidance is published in the Federal
Register on April 13, 2022.
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-2021-D-0603 for ``Denture Base Resins--Performance Criteria for
Safety and Performance Based Pathway; Guidance for Industry and Food
and Drug Administration Staff'' or Docket No. FDA-2021-D-0604 for
``Facet Screw Systems--Performance Criteria for Safety and Performance
Based Pathway; Guidance for Industry and Food and Drug Administration
Staff.'' 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
``Denture Base Resins--Performance Criteria for Safety and Performance
Based Pathway; Guidance for Industry and Food and Drug Administration
Staff'' or ``Facet Screw Systems--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff'' to the Office of Policy, Center for Devices
[[Page 21890]]
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
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.
SUPPLEMENTARY INFORMATION:
I. Background
These 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.'' \1\ 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 guidances,
rather than using direct predicate comparison testing for some of the
performance characteristics.
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\1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
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A notice of availability of the draft guidances ``Denture Base
Resins'' and ``Facet Screw Systems'' appeared in the Federal Register
of August 30, 2021 (86 FR 48430). FDA considered comments received on
the ``Denture Base Resins'' and revised the guidance as appropriate by
clarifying what information should be included in premarket submissions
for denture resins that are additively manufactured. There were no
comments received for the ``Facet Screw Systems'' guidance.
These guidance documents are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The guidance
documents represent the current thinking of FDA on performance criteria
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 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of either ``Denture Base Resins--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff (document number
20001)'' or ``Facet Screw Systems--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff (document number 21001)'' may send an email
request to [email protected] 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 these guidance documents. 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:
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21 CFR part or guidance Topic OMB control No.
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807, subpart E............................... Premarket notification.. 0910-0120
``Requests for Feedback and Meetings for Q-submissions; Pre- 0910-0756
Medical Device Submissions: The Q-Submission submissions.
Program''.
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Dated: April 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07934 Filed 4-12-22; 8:45 am]
BILLING CODE 4164-01-P