Safety and Performance Based Pathway Device-Specific Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability, 48430-48431 [2021-18592]

Download as PDF 48430 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Dated: August 17, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–18586 Filed 8–27–21; 8:45 am] BILLING CODE 4164–01–P 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 Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: 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Based Pathway—specifically, ‘‘Denture Base Resins—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’ and ‘‘Facet Screw Systems—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.’’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 These draft guidance documents are not final nor are they in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by October 29, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:40 Aug 27, 2021 Jkt 253001 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; 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 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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-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 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 E:\FR\FM\30AUN1.SGM 30AUN1 48431 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 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, 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These guidance documents are also available at https://www.regulations.gov and at https://www.fda.gov/regulatory- information/search-fda-guidancedocuments. 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 CDRH-Guidance@ fda.hhs.gov 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: 21 CFR part; guidance; or FDA form Topic 807, subpart E .............................................................................................................. ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’. Premarket notification ............................... Q-submissions; Pre-submissions ............. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES 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. [Docket No. FDA–2018–D–1216] Electronic Common Technical Document; Data Standards; Specifications for Electronic Common Technical Document Validation Criteria Food and Drug Administration, Health and Human Services (HHS). AGENCY: VerDate Sep<11>2014 18:40 Aug 27, 2021 Jkt 253001 ACTION: Notice. The Food and Drug Administration’s (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that FDA will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors as described in the Specifications for eCTD Validation Criteria. Validation errors 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria. DATES: Rejection for failing to pass either eCTD validation 1551 or 1553 under a submission to CDER will begin on October 18, 2021. FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug Evaluation and Research, Food and SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 OMB control No. 0910–0120 0910–0756 Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993–0002, 301– 796–7997, Jonathan.Resnick@ fda.hhs.gov. FDA’s CDER is issuing this Federal Register notice to announce that eCTD validations 1551 and 1553 have been added to the Specifications for eCTD Validation Criteria (available at https:// www.fda.gov/media/87056/download) as high validation errors. Beginning October 18, 2021, FDA will reject submissions that fail either of these validations. Under section 745A(a) (21 U.S.C. 379k–1(a)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which FDA has SUPPLEMENTARY INFORMATION: E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48430-48431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18592]


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

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.

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

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:
     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; 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 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 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are 
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 ``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 [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 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:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------


    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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