[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]
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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Manufacturers; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Voluntary Malfunction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this notice of availability for this draft guidance document to help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 This draft guidance is not final nor is it for implementation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DATES: Submit either electronic or written comments on the draft
guidance by February 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
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\1\ See Pilot Program for Medical Device Reporting on
Malfunctions, 80 FR 50010.
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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:
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21 CFR part; guidance; or FDA OMB control
form Topic No.
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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.
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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