Notice2021-16034
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40593-40595]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16034]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6730]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Reporting
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 27, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0437. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#9cccceddcfe8fdfafadcfaf8fdb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="411113001235202727012725206f2929326f262e37">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Extension
This information collection supports FDA regulations and FDA's
Medical Device Reporting program. Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(a),
(b), and (c)) requires user facilities, manufacturers, importers, and
distributors of medical devices to report adverse events involving
medical
[[Page 40594]]
devices to FDA. These provisions are codified in part 803 (21 CFR part
803), Medical Device Reporting. As amended most recently by the FDA
Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), medical device
manufacturers and importers must submit medical device reports (MDRs)
using FDA's electronic submission system. User facilities, however, may
elect to submit reports using paper-based Form FDA 3500A--MedWatch--
Mandatory Reporting (approved under OMB control number 0910-0291). The
regulations also establish recordkeeping requirements and provide for
certain exemptions, variances, or alternative forms of reporting.
Exemptions and/or variances from individual reporting must be requested
in writing and must receive Agency approval. Additionally, the
regulations permit user facilities to submit paper-based annual
reports, for which we have developed Form FDA 3419 entitled ``Medical
Device Reporting Annual User Facility Report.''
This information collection also includes the use of existing
formats such as Form FDA 3500A \1\--MedWatch--Mandatory Reporting to
allow manufacturers to summarize in a single report multiple events
with shared characteristics for device associated reportable
malfunction events. For example, the Voluntary Malfunction Summary
Reporting Program (VMSRP) \2\ provides recommendations for
manufacturers of certain devices to submit a single report that
summarizes multiple device associated reportable malfunction events on
a quarterly basis. The VMSRP was established under section
519(a)(1)(B)(ii) of the FD&C Act and reflects goals for streamlining
malfunction reporting as outlined in the Medical Device User Fee
Amendments (MDUFA) IV ``Commitment Letter'' for 2018 through 2022
agreed to by FDA and industry and submitted to Congress. The Commitment
Letter was finalized with the passage of FDARA on August 18, 2017, and,
as passed, is entitled ``MDUFA Performance Goals And Procedures, Fiscal
Years 2018 Through 2022.'' \3\
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\1\ Form FDA 3500A is approved under OMB control number 0910-
0291.
\2\ In the Federal Register of August 17, 2018 (83 FR 40973),
FDA issued a notification permitting manufacturers to report certain
device malfunction MDRs in summary form on a quarterly basis.
\3\ Available at: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf</a>.
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The information that is obtained from this information collection
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate measures to protect the public health.
Complete, accurate, and timely adverse event information is necessary
for the identification of emerging device problems so the Agency can
protect the public health under section 519 of the FD&C Act. FDA makes
the releasable information available to the public for downloading on
its website. Respondents are manufacturers and importers of medical
devices and device user facilities.\4\
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\4\ Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or
outpatient treatment facility as defined in Sec. 803.3 (21 CFR
803.3), which is not a physician's office (also defined in Sec.
803.3).
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In the Federal Register of April 29, 2021 (86 FR 22671), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. Upon our own
review, however, we have updated submission figures from our VMSRP
program and supplemental reports under Sec. 803.56 (21 CFR 803.56) to
reflect an increase in submissions. Since publication of our 60-day
notice, therefore, we have modified our estimated burden for collection
of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity/21 CFR section FDA form No. Number of responses per Total annual Average burden per Total hours \2\
respondents respondent responses response
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Exemptions/Variances--803.19........ .............. 6 135.8 815 0.10 (6 minutes).......... 82
User Facility Reporting--803.30 and .............. 271 17.2 4,661 0.35 (21 minutes)......... 1,631
803.32.
User Facility Annual Reporting-- 3,419 93 2 186 1......................... 186
803.33.
Importer Reporting, Death and .............. 112 440.25 49,308 0.10 (6 minutes).......... 4,931
Serious Injury--803.40 and 803.42.
Manufacturer Reporting--803.50, .............. 1,799 809.83 1,456,884 0.10 (6 minutes).......... 145,688
803.52 and 803.53.
Voluntary Malfunction Summary .............. 67 695.15 46,575 0.10 (6 minutes).......... 4,658
Reporting Program.
Supplemental Reports--803.56........ .............. 1,291 438 565,458 0.10 (6 minutes).......... 56,546
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Total........................... .............. .............. .............. .............. .......................... 213,722
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
The number of respondents to the information collection is based on
MDRs received by FDA recently. The annual frequency per response and
total annual responses shown are based on the number of MDRs reported
during the same period. Based on the scope and conditions of the VMSRP
and our experience with MDR reporting, FDA estimates that approximately
10 percent of malfunction reports would continue to be submitted as
individual reports. Approximately 62 percent of the manufacturer
reports received under Sec. Sec. 803.50, 803.52 and 803.53 are
malfunction reports (903,268 of the 1,456,884 total annual responses
received in 2020).
Supplemental Reports--Sec. 803.56. We have increased our estimate,
of the number of supplemental reports to reflect a corresponding
increase of annual submissions, as reflected in table 1, row 7.
Voluntary Malfunction Summary Reporting Program. The VMSRP includes
the same respondent pool as individual manufacturer reporting. Based on
a current review of Agency data, we have increased our estimate to
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reflect an increase in annual submissions, as reflected in table 1, row
6.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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MDR Procedures--803.17.......... 1,799 1 1,799 3.3 5,937
MDR Files--803.18............... 1,799 1 1,799 1.5 2,699
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Total....................... .............. .............. .............. .............. 8,636
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of respondents in table 2 is based on the MDRs reported
to FDA's internal databases recently. We believe that the majority of
respondents (manufacturers, user facilities, and importers) have
already established written procedures and MDR files to document
complaints and information to meet the MDR requirements as part of
their internal quality control system.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours \2\
respondents respondent disclosures
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Importer Reporting, Death and Serious Injury-- 112 25 2,800 0.35 (21 minutes)................... 980
803.40 and 803.42.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
The number of respondents for each CFR section in table 3 was
identified from the MDRs reported to FDA's internal databases during
the period recently.
Since the publication of the 60 day notice we have adjusted our
burden estimate. Our estimated burden for the information collection
reflects an increase of 155,360 total burden hours and a corresponding
increase of 1,566,458 total annual responses. This increase corresponds
with data obtained from our database.
Dated: July 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16034 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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