Notice2024-19413
Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
August 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 168 (Thursday, August 29, 2024)</title>
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[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Notices]
[Pages 70193-70195]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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]]
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Voluntary
[[Page 70195]]
Malfunction Summary Reporting (VMSR) Program for Manufacturers'' may
send an email request to <a href="/cdn-cgi/l/email-protection#195a5d4b51345e6c707d78777a7c597f7d783771716a377e766f"><span class="__cf_email__" data-cfemail="a5e6e1f7ed88e2d0ccc1c4cbc6c0e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a> 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
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