Select Updates for Biocompatibility of Certain Devices in Contact With Intact Skin; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 65410-65412 [2020-22876]

Download as PDF 65410 Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices the complex thermomechanical behavior of nitinol, there are unique considerations when assessing the safety and performance of nitinol devices. The Agency has developed this guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol. These recommendations are intended to be general and apply to medical devices that have at least one patient contacting component comprised of nitinol. The following technical areas are covered by this guidance: general information, mechanical testing, corrosion, biocompatibility, and labeling of nitinol devices. A notice of availability of the draft guidance appeared in the Federal Register of April 19, 2019 (84 FR 16516). FDA considered comments received and revised the guidance as appropriate in response to the comments, including minor technical clarifications. 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Technical Considerations for NonClinical Assessment of Medical Devices containing Nitinol’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17013 and the complete guidance title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 This 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: OMB Control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)‘‘. ‘‘FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act‘‘. ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff‘‘. 801 .............................................................................................. 820 .............................................................................................. Premarket notification ................................................................ Premarket approval .................................................................... Humanitarian Device Exemption ............................................... Investigational Device Exemption .............................................. De Novo classification process .................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 513(g) Request for Information .................................................. 0910–0705 Q-submissions ........................................................................... 0910–0756 Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice; Quality System Regulation. 0910–0485 0910–0073 Dated: October 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22877 Filed 10–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0350] jbell on DSKJLSW7X2PROD with NOTICES This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on technical considerations for non-clinical assessment of medical devices containing nitinol. 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. 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. VerDate Sep<11>2014 17:41 Oct 14, 2020 Jkt 253001 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. SUMMARY: 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. DATES: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 You may submit comments on any guidance at any time as follows: ADDRESSES: 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 E:\FR\FM\15OCN1.SGM 15OCN1 Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:41 Oct 14, 2020 Jkt 253001 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 ‘‘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 selfaddressed 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-fdaguidance-documents/use-international- PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 65411 standard-iso-10993-1-biologicalevaluation-medical-devices-part-1evaluation-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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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 E:\FR\FM\15OCN1.SGM 15OCN1 65412 Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices Skin’’ may send an email request to CDRH-Guidance@fda.hhs.gov 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: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)‘‘. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff‘‘. 800, 801, and 809 ....................................................................... 803 .............................................................................................. Premarket notification ................................................................ Premarket approval .................................................................... Humanitarian Device Exemption ............................................... Investigational Device Exemption .............................................. De Novo classification process .................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Q-submissions ........................................................................... 0910–0756 Medical Device Labeling Regulations ........................................ Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. 0910–0485 0910–0437 820 .............................................................................................. Dated: October 8, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22876 Filed 10–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3926] Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to SUMMARY: serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before December 14, 2020 will be given 0910–0073 first consideration for membership on the DGMPAC and Panels of the MDAC. Nominations received after December 14, 2020 will be considered for nomination to the committee as later vacancies occur. All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, contact the following persons listed in table 1: TABLE 1—PRIMARY CONTACT AND COMMITTEE OR PANEL jbell on DSKJLSW7X2PROD with NOTICES Primary contact person Committee or panel Joannie Adams-White, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5561, Silver Spring, MD 20993, 301– 796–5421, email: Joannie.Adams-White@fda.hhs.gov. Aden S. Asefa, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993, 301–796–0400, email: Aden.Asefa@fda.hhs.gov. VerDate Sep<11>2014 17:41 Oct 14, 2020 Jkt 253001 PO 00000 Frm 00074 Fmt 4703 Medical Devices Dispute Resolution Panel Dental Products Panel, Immunology Devices Panel, Microbiology Devices Panel, Neurological Devices Panel, Ophthalmic Devices Panel, DGMPAC. Sfmt 4703 E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[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]


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

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.

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

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:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    Dated: October 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22876 Filed 10-14-20; 8:45 am]
BILLING CODE 4164-01-P

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