Document ID: FDA-2015-N-3815-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishment Registration and Device Listing for Manufacturers and Importers of Devices
Posted Date: 2022-06-24T04:00Z

[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37859-37861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3815]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Establishment 
Registration and Device Listing for Manufacturers and Importers of 
Devices

AGENCY: Food and Drug Administration, 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: Fax written comments on the collection of information by July 
25, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0625. 
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.

Establishment Registration and Device Listing for Manufacturers and 
Importers of Devices--21 CFR Part 807, Subparts A Through D

OMB Control Number 0910-0625--Extension

    Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360) and implementing regulations in 21 CFR part 807, 
subparts A through D (part 807, subparts A through D), medical device 
establishment owners and operators are required to electronically 
submit establishment registration and device listing information. 
Complete and accurate registration and listing information is necessary 
to accomplish a number of statutory and regulatory objectives, such as: 
(1) identification of establishments producing marketed medical 
devices; (2) identification of establishments producing a specific 
device when that device is in short supply or is needed for national 
emergency; (3) facilitation of recalls for devices marketed by owners 
and operators of device establishments; (4) identification and 
cataloging of marketed devices; (5) administering postmarketing 
surveillance programs for devices; (6) identification of devices 
marketed in violation of the law; (7) identification and control of 
devices imported into the country from foreign establishments; and (8) 
scheduling and planning inspections of registered establishments under 
section 704 of the FD&C Act (21 U.S.C. 374).
    Respondents to this information collection are owners or operators 
of establishments that engage in the manufacturing, preparation, 
propagation, compounding, or processing of a device or devices, who 
must register their establishments and

[[Page 37860]]

submit listing information for each of their devices in commercial 
distribution. Notwithstanding certain exceptions, foreign device 
establishments that manufacture, prepare, propagate, compound, or 
process a device that is imported or offered for import into the United 
States must also comply with the registration and listing requirements. 
The number of respondents is based on data from the FDA Unified 
Registration and Listing System (FURLS). Burden estimates are based on 
recent experience with the medical device registration and listing 
program, electronic system operating experience, and previous data 
estimates.
    In the Federal Register of February 8, 2022 (87 FR 7187), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                     Annual
            21 CFR section; activity                Number of    frequency  per   Total annual             Hours per  response              Total hours
                                                   respondents      response        responses                                                   \2\
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807.20(a)(5); \3\ Initial submittal of                    4,125               1           4,125  1.75...................................           7,219
 manufacturer information by initial importers.
807.20(a)(5); \4\ Annual submittal of                     4,125               1           4,125  0.1 (6 minutes)........................             413
 manufacturer information by initial importers.
807.21(a); \3\ Creation of electronic system              5,355               1           5,355  0.5 (30 minutes).......................           2,678
 account.
807.21(b); \4\ Annual request for waiver from                 1               1               1  1......................................               1
 electronic registration & listing.
807.21(b); \3\ Initial request for waiver from                1               1               1  1......................................               1
 electronic registration & listing.
807.22(a); \3\ Initial registration & listing..           5,355               1           5,355  1......................................           5,355
807.22(b)(1); \4\ Annual registration..........          28,496               1          28,496  0.5 (30 minutes).......................          14,248
807.22(b)(2); \4\ Other updates of registration           2,671               1           2,671  0.5 (30 minutes).......................           1,336
807.22(b)(3); \4\ Annual update of listing               26,871               1          26,871  0.5 (30 minutes).......................          13,436
 information.
807.22(b)(4) Changes to listing information
 (outside of annual listing requirement
 period):
    Voluntary reporting of transfer of 510(k)             4,080               1           4,080  0.25 (15 minutes)......................           1,020
     clearance (outside of annual listing
     requirement period).
    Submission of 510(k) transfer documentation           2,033               1           2,033  4......................................           8,132
     when more than one party lists the same
     510(k).
807.26(e); \4\ Labeling & advertisement                       9               1               9  1......................................               9
 submitted at FDA request.
807.34(a); \3\ Initial registration & listing                 1               1               1  1......................................               1
 when electronic filing waiver granted.
807.34(a); \4\ Annual registration & listing                  1               1               1  1......................................               1
 when electronic filing waiver granted.
807.40(b)(3); \4\ Annual update of U.S. agent             6,101               1           6,101  0.5 (30 minutes).......................           3,051
 information.
807.40(b)(2); \4\ U.S. agent responses to FDA             1,535               1           1,535  0.25 (15 minutes)......................             384
 requests for information.
807.41(a); \4\ Identification by foreign                 14,017               1          14,017  0.5 (30 minutes).......................           7,009
 establishments of importers, defined in 807.3,
 of the establishment's devices.
807.41(b); \4\ Identification of other                   14,017               1          14,017  0.5 (30 minutes).......................           7,009
 importers (defined in 807.3(x)-(y)) that
 facilitate import by foreign establishments.
                                                --------------------------------------------------------------------------------------------------------
        Total..................................  ..............  ..............  ..............  .......................................          71,303
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals are rounded to the nearest whole number.
\3\ One-Time Burden--Firm only provides initially.
\4\ Recurring Burden--Firm is required to review annually.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                     Annual
                 21 CFR section                     Number of     frequency per   Total annual              Hours per  record               Total hours
                                                   respondents    recordkeeper       records
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807.25(d); \2\ Labeling and advertisements               17,032               4          68,128  0.5 (30 minutes).......................          34,064
 available for review.
807.26; \2\ List of officers, directors, and             33,851               1          33,851  .25 (15 minutes).......................           8,463
 partners.
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    Total......................................  ..............  ..............  ..............  .......................................          42,527
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Recurring burden--Firm is required to keep records.

    Our estimates for creating new user accounts under Sec.  807.21(a) 
are based on the recent number of owners or operators. An owner or 
operator only creates an account one time when they register for the 
first time (initial

[[Page 37861]]

registration). Once the account is created, the owner or operator uses 
the account as long as the establishment is registered. If an owner or 
operator changes, the new owner or operator creates a new owner or 
operator account and transfers the ownership of the establishment to 
their owner or operator account. Once they create an owner or operator 
account, they use the account for as long as the company is registered. 
Under Sec.  807.22(b)(4), changes to listing information may be made at 
times outside of the annual listing requirement period, such as when a 
change is made to a previously listed device.
    The draft guidance entitled ``Transfer of a Premarket Notification 
(510(k)) Clearance--Questions and Answers'' (December 2014), which 
contained instructions for the proposed voluntary information 
collection, has recently been withdrawn. While notification of transfer 
of ownership information is not currently required, our medical device 
registration and listing website \1\ communicates procedures for 
notifying FDA of the transfer of a premarket notification (510(k)) 
clearance from one person to another. The notification is used to 
ensure public information in FDA's databases about the current 510(k) 
holder for a specific device(s) is accurate and up to date. Although 
submission of information regarding the transfer of a 510(k) clearance 
is not required under the regulations, we regularly receive such 
notifications from respondents.
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    \1\ https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
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    We estimate that annually 78 percent of 510(k)s may be initially 
listed or updated outside of the annual registration requirement (about 
4,080 510(k)s per year). We assume it will take 15 minutes for each 
listing, for a total reporting burden of 1,020 hours.
    We estimate 2,033 instances of more than one party claiming to be a 
510(k) holder for a specific device as part of annual registration and 
listing. We determined our estimate by identifying the average number 
of unique 510(k) device listings entered in FURLS between fiscal years 
2017 and 2019 that conflict with a listing already entered by another 
party (5,304), dividing that number by the number of years (3) and 
multiplying by the average number of parties claiming to be the 510(k) 
holder when there is a conflict in the current FURLS database (2.3), 
then dividing the result by 2 (because only one company per listing 
will submit the appropriate documentation to show that they are the 
current 510(k) holder).
    The registration and listing website identifies potential 
documentation a party could submit to FDA to establish the transfer of 
a 510(k) clearance to a new owner or operator. Based on the amount of 
time to locate the information, copy it, and submit a copy, we assume 
it takes respondents an average of 4 hours to establish the transfer of 
a 510(k) clearance.
    The estimate for Sec.  807.25(d) in table 2 of this document 
(recordkeeping burden) reflects the requirement that owners or 
operators maintain a historical file containing the labeling and 
advertisements in use. The estimate for Sec.  807.26 reflects the 
requirement that owners or operators keep a list of officers, 
directors, and partners for each establishment. Owners or operators 
will need to provide this information only when requested by FDA. 
However, it is assumed that some effort will need to be expended to 
keep such records current.
    The recurring burden for the data collection under Sec.  807.41 
(import-related information provided by foreign companies exporting to 
the United States) was estimated based on data from previous years. 
Foreign companies identify readily available contact information at the 
time of registration. After completing their initial registration, they 
are required to review the importer information annually. When they 
review the importer information annually, they simply verify the 
importer information is accurate. If it is and no changes are needed, 
the foreign establishment's official correspondent checks the 
certification and submits the annual registration. If they need to make 
changes to the importer information, they can do so at any time and use 
a spreadsheet to update more than one importer at a time to their 
registration. The use of the spreadsheet reduces the burden to the 
official correspondent of the foreign establishment.
    Our estimated burden for the information collection reflects an 
overall increase of 10,880 hours and a corresponding increase of 28,430 
responses/records. We attribute this adjustment to an increase in the 
number of submissions we received over the last 3 years.

    Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13522 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P