[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40593-40595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
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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

[[Page 40595]]

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