[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22671-22674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08962]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6730]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection associated with 
requirements for medical device reporting for user facilities, 
manufacturers, importers, and distributors of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by June 28, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 28, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-2017-N-6730 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Device Reporting.'' 
Received comments,

[[Page 22672]]

those filed in a timely manner (see ADDRESSES), 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.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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, which is 
not a physician's office (also defined in Sec.  803.3).

---------------------------------------------------------------------------

[[Page 22673]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of
        Activity/21 CFR section          FDA  form      Number of     responses per   Total  annual      Average burden  per response       Total hours
                                            No.        respondents     respondent       responses                                               \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions/Variances--803.19..........  ...........              85               4             340  1..................................             340
User Facility Reporting--803.30 and     ...........             520           10.06           5,232  0.35 (21 minutes)..................           1,831
 803.32.
User Facility Annual Reporting--803.33         3419             159               1             159  1..................................             159
Importer Reporting, Death and Serious   ...........             578               1             578  1..................................             578
 Injury--803.40 and 803.42.
Manufacturer Reporting--803.50, 803.52  ...........           1,240          272.50         337,900  0.10 (6 minutes)...................          33,790
 and 803.53.
Voluntary Malfunction Summary           ...........           1,240           54.47          67,546  0.10 (6 minutes)...................           6,755
 Reporting Program.
Supplemental Reports--803.56..........  ...........           1,050          128.71         135,148  0.10 (6 minutes)...................          13,515
                                       -----------------------------------------------------------------------------------------------------------------
    Total.............................  ...........  ..............  ..............  ..............  ...................................          56,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. FDA estimates that approximately 10 percent of 
malfunction reports are submitted. Approximately 67 percent of the 
manufacturer reports received under 21 CFR 803.50, 803.52, and 803.53 
are malfunction reports.
    Supplemental Reports--21 CFR 803.56. We estimate that, at most, the 
number of supplemental reports is approximately one third of the total 
number of individual reports and summary reports submitted annually. 
Therefore, our estimate of the number of responses per respondent is 
128.71.
    Voluntary Malfunction Summary Reporting Program. The VMSRP includes 
the same respondent pool as individual manufacturer reporting. We 
expect that a summary report will take approximately the same amount of 
time to prepare as an individual report. (Note: device-led combination 
products are included in the burden estimate for the VMSRP.) As 
discussed in section I of the proposed VMSRP, FDA's Pilot Program for 
Medical Device Reporting on Malfunctions showed an 87 percent reduction 
in the volume of reporting for malfunction reports with use of 
malfunction summary reporting. Assuming 90 percent of malfunction 
reports are submitted in summary reports, we estimate that 
manufacturers would submit an average of 54.47 summary reports annually 
under the program.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of      records per    Total annual       Average  burden per  recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17......................           1,240               1           1,240  3.3.......................................           4,092
MDR Files--803.18...........................           1,240               1           1,240  1.5.......................................           1,860
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           5,952
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. We have therefore adjusted our 
estimate downward.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of    disclosures per   Total annual         Average burden  per disclosure         Total hours
                                                respondents      respondent      disclosures                                                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and Serious                    578               25          14,450  0.35 (21 minutes)........................           5,058
 Injury--803.40 and 803.42.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.


[[Page 22674]]

    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.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no changes to our burden 
estimate.

    Dated: April 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08962 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P