Voluntary Malfunction Summary Reporting Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 75634-75635 [2022-26729]

Download as PDF 75634 Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Notices regarding this collection contact Shelly Winston at 410–786–3694.) Dated: December 6, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2022–26807 Filed 12–8–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–2873] Voluntary Malfunction Summary Reporting Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.’’ We are publishing this notice of availability for this draft guidance document to help manufacturers better understand and use the VMSR Program. It is intended to further explain, but not change, the conditions of the VMSR Program. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by February 7, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:50 Dec 08, 2022 Jkt 259001 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– 2022–D–2873 for ‘‘Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.’’ 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 ‘‘Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers’’ to the Office of Policy, 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: Michelle Rios, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1116, Silver Spring, MD 20993–0002, 301–796–6107 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background Each year, FDA receives over 2 million medical device reports (MDRs) of suspected device-related deaths, serious injuries, and malfunctions. The MDR Program is one of the postmarket surveillance tools that FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments. Malfunction reports represent most of the MDRs received by FDA on an annual basis. As part of FDA’s postmarket surveillance for E:\FR\FM\09DEN1.SGM 09DEN1 Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Notices devices, the Agency reviews the MDRs submitted by both mandatory and voluntary reporters. The VMSR Program (the Program) began in 2018 when FDA issued a notification in the Federal Register of August 17, 2018 (83 FR 40973) of an order granting an alternative under 21 CFR 803.19 that permits manufacturers of devices in eligible product codes to report certain device malfunction MDRs in summary form on a quarterly basis, subject to the conditions of the alternative. The Program is intended to streamline reporting for device malfunctions as outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. As such, it is intended to yield benefits for FDA, the public, and manufacturers, such as increasing transparency for the public, helping FDA to process certain malfunction reports more efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers. FDA implemented the Program only after the Agency had conducted a pilot program 1 that demonstrated the value of a program for summary medical device reporting on malfunctions to public health, better use of Agency resources, and promotion of public transparency. This draft guidance describes and clarifies several aspects of the Program. 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/guidance- documents-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 21007 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does 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 regulations, guidance, and forms have been approved by OMB as listed in the following table: 21 CFR part; guidance; or FDA form Topic 803 ................................. Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ................................ 820 ................................. Dated: December 5, 2022. Lauren K. Roth, Associate Commissioner for Policy. ACTION: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–4599] Content of Human Factors Information in Medical Device Marketing Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. OMB control No. Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Content of Human Factors Information in Medical Device Marketing Submissions.’’ This draft guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health to facilitate the efficiency of the FDA review process. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by March 9, 2023 to ensure that the SUMMARY: [FR Doc. 2022–26729 Filed 12–8–22; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 The draft guidance includes information on FDA’s approach to determining the eligibility of product codes for the Program and the conditions for submitting MDRs for device malfunctions in summary format under the Program. The draft guidance also includes information on how manufacturers may submit information in the summary reporting format, including instructions on how to complete applicable sections of Form FDA 3500A. 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 ‘‘Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.’’ 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. 17:50 Dec 08, 2022 Jkt 259001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 0910–0437 0910–0073 Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 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 1 See Pilot Program for Medical Device Reporting on Malfunctions, 80 FR 50010. VerDate Sep<11>2014 75635 E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75634-75635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26729]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2873]


Voluntary Malfunction Summary Reporting Program for 
Manufacturers; 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 ``Voluntary Malfunction 
Summary Reporting (VMSR) Program for Manufacturers.'' We are publishing 
this notice of availability for this draft guidance document to help 
manufacturers better understand and use the VMSR Program. It is 
intended to further explain, but not change, the conditions of the VMSR 
Program. This draft guidance is not final nor is it for implementation 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 7, 2023 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-2022-D-2873 for ``Voluntary Malfunction Summary Reporting (VMSR) 
Program for Manufacturers.'' 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 draft guidance document entitled 
``Voluntary Malfunction Summary Reporting (VMSR) Program for 
Manufacturers'' to the Office of Policy, 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: Michelle Rios, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1116, Silver Spring, MD 20993-0002, 301-796-6107 or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Each year, FDA receives over 2 million medical device reports 
(MDRs) of suspected device-related deaths, serious injuries, and 
malfunctions. The MDR Program is one of the postmarket surveillance 
tools that FDA uses to monitor device performance, detect potential 
device-related safety issues, and contribute to benefit-risk 
assessments. Malfunction reports represent most of the MDRs received by 
FDA on an annual basis. As part of FDA's postmarket surveillance for

[[Page 75635]]

devices, the Agency reviews the MDRs submitted by both mandatory and 
voluntary reporters.
    The VMSR Program (the Program) began in 2018 when FDA issued a 
notification in the Federal Register of August 17, 2018 (83 FR 40973) 
of an order granting an alternative under 21 CFR 803.19 that permits 
manufacturers of devices in eligible product codes to report certain 
device malfunction MDRs in summary form on a quarterly basis, subject 
to the conditions of the alternative. The Program is intended to 
streamline reporting for device malfunctions as outlined in the Medical 
Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. As 
such, it is intended to yield benefits for FDA, the public, and 
manufacturers, such as increasing transparency for the public, helping 
FDA to process certain malfunction reports more efficiently, allowing 
both FDA and the public to identify malfunction trends more readily, 
and reducing the burden on manufacturers. FDA implemented the Program 
only after the Agency had conducted a pilot program \1\ that 
demonstrated the value of a program for summary medical device 
reporting on malfunctions to public health, better use of Agency 
resources, and promotion of public transparency.
---------------------------------------------------------------------------

    \1\ See Pilot Program for Medical Device Reporting on 
Malfunctions, 80 FR 50010.
---------------------------------------------------------------------------

    This draft guidance describes and clarifies several aspects of the 
Program. The draft guidance includes information on FDA's approach to 
determining the eligibility of product codes for the Program and the 
conditions for submitting MDRs for device malfunctions in summary 
format under the Program. The draft guidance also includes information 
on how manufacturers may submit information in the summary reporting 
format, including instructions on how to complete applicable sections 
of Form FDA 3500A.
    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 ``Voluntary 
Malfunction Summary Reporting (VMSR) Program for Manufacturers.'' 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Voluntary Malfunction Summary Reporting (VMSR) Program for 
Manufacturers'' may send an email request to [email protected] 
to receive an electronic copy of the document. Please use the document 
number 21007 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does 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 regulations, guidance, and forms 
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                             OMB  control
              form                        Topic                 No.
------------------------------------------------------------------------
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: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26729 Filed 12-8-22; 8:45 am]
BILLING CODE 4164-01-P
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