[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Notices]
[Pages 70193-70195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Voluntary Malfunction Summary Reporting Program for 
Manufacturers; 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 a final guidance entitled ``Voluntary Malfunction 
Summary Reporting (VMSR) Program for Manufacturers.'' This final 
guidance document is intended to help manufacturers better understand 
and use the VMSR Program. This guidance describes and clarifies several 
aspects of the VMSR Program, including the FDA's approach to 
determining the eligibility of product codes for the program and the 
conditions for submitting medical device reports (MDRs) for device 
malfunctions in summary format under the program.

DATES: The announcement of the guidance is published in the Federal 
Register on August 29, 2024.

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-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

[[Page 70194]]

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 
``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 James Myers, 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 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 devices, the Agency reviews the MDRs 
submitted by both mandatory and voluntary reporters.
    FDA has determined that for many devices, it is appropriate to 
permit manufacturers to submit malfunction summary reports on a 
quarterly basis, for certain malfunctions related to devices with 
certain product codes, instead of individual, 30-day malfunction 
reports. FDA is issuing this final guidance document to help 
manufacturers better understand and use the VMSR Program. This guidance 
describes and clarifies several aspects of the VMSR Program, including 
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 program began in 2018 when FDA 
issued a notification in the Federal Register 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 (83 FR 40973). FDA's VMSR Program 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.
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 9, 2022 (87 FR 75634). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments. Changes from the draft to the final guidance include 
that the final guidance provides further clarification regarding how 
FDA determines the eligibility of a product code for inclusion in the 
VMSR Program and the conditions for submitting medical device reports 
for device malfunctions in summary format under the program. The final 
guidance also provides additional examples to facilitate submission 
utilizing Form FDA 3500A. It also clarifies how manufacturers may opt 
out of the VMSR program and provides links to an updated website to 
find product codes that are eligible for inclusion in the voluntary 
VMSR program.
    Published elsewhere in this edition of the Federal Register, FDA is 
issuing a notification announcing a minor, technical modification to 
the VMSR Program alternative granted under 21 CFR 803.19, to align with 
the most current version of Form FDA 3500A and with current adverse 
event codes. This guidance is consistent with that modification.
    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 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 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

[[Page 70195]]

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 
GUI00021007 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

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       21 CFR part; guidance; or FDA form                            Topic                      OMB control No.
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803............................................  Medical Device Reporting....................          0910-0437
820............................................  Current Good Manufacturing Practice (CGMP);           0910-0073
                                                  Quality System (QS) Regulation.
806............................................  Medical Devices; Reports of Corrections and           0910-0359
                                                  Removals.
Form FDA 3500A.................................  MedWatch: Adverse Event and Product                   0910-0291
                                                  Experience Reporting System.
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    Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19413 Filed 8-28-24; 8:45 am]
BILLING CODE 4164-01-P