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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
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 Devices; Device Tracking21
CFR Part 821
OMB Control Number 09100442
Extension Section 519e1 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
360ie1, as amended by Food and Drug Administration Modernization Act Pub. L. 105115, provides that FDA
may require by order that a manufacturer adopt a method for tracking a class II or III medical device, if the device meets one of the three following criteria: 1 The failure of the device would be reasonably likely to have serious adverse health consequences, 2 the device is intended to be implanted in the human body for more than 1 year referred to as a tracked implant, or 3 the device is life-sustaining or life-supporting referred to as a tracked l/s-l/s device and is used outside a device user facility.
Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information.
Manufacturers and FDA where necessary use the data to: 1 Expedite the recall of distributed medical devices that are dangerous or defective and 2

facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device.
In addition, the regulations include provisions for: 1 Exemptions and variances; 2 system and content requirements for tracking; 3
obligations of persons other than device manufacturers, e.g., distributors; 4
records and inspection requirements; 5
confidentiality; and 6 record retention requirements.
Respondents for this collection of information are medical device manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals.
The annual hourly burden for respondents involved with medical device tracking is estimated to be 615,380 hours per year. The burden estimates cited in tables 1 through 3 are based on the approximate number of device tracking orders, 12 annually.
FDA estimates that approximately 22,000 respondents may be subject to tracking reporting requirements.
Under 821.25a 21 CFR 821.25a, device manufacturers subject to FDA
tracking orders must adopt a tracking method that can provide certain device, patient, and distributor information to FDA within 3 to 10 working days.
Assuming one occurrence per year, FDA
estimates it would take a firm 20 hours to provide FDA with location data for all tracked devices and 56 hours to identify all patients and/or multiple distributors possessing tracked devices.

Under 821.25d manufacturers must notify FDA of distributor noncompliance with reporting requirements. Based on the number of audits manufacturers conduct annually, FDA estimates it would receive no more than one notice in any year, and that it would take 1 hour per incident.
Under 821.30c2 21 CFR
821.30c2, multiple distributors must provide data on current users of tracked devices, current device locations, and other information, upon request from a manufacturer or FDA. FDA has not made such a request and is not aware of any manufacturer making a request.
Assuming one multiple distributor receives one request in a year from either a manufacturer or FDA, and that lists may be generated electronically, the Agency estimates a burden of 1 hour to comply.
Under 821.30d distributors must verify data or make required records available for auditing, if a manufacturer provides a written request. FDAs estimate of the burden for distributor audit responses assumes that manufacturers audit database entries for 5 percent of tracked devices distributed.
Each audited database entry prompts one distributor audit response. Because lists may be generated electronically, FDA estimates a burden of 1 hour to comply.
In the Federal Register of November 5, 2020 85 FR 70634, FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of responses per respondent
Number of respondents
Activity; 21 CFR part
Average burden per response
Total annual responses
Total hours
Discontinuation of business821.1d
Exemption or variance821.2 and 821.30e
Notification of failure to comply821.25d
Multiple distributor data821.30c2

1
1 1
1

1
1 1
1

1
1 1
1

1
1 1
1

1
1 1
1

Total

4

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

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TABLE 2ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of recordkeepers
Activity; 21 CFR part Tracking information821.25a
Record of tracking data821.25b
Standard operating procedures821.25c 2
Manufacturer data audit821.25c3

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Number of records per recordkeeper
12
12
12
12

Fmt 4703

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1
46,260
1 1,124

Total annual records 12
555,120
12
13,488

E:FRFM16FEN1.SGM

16FEN1

Average burden per recordkeeping 76
1 63
1

Total hours 912
555,120
756
13,488