Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
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 cle...
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 January 4, 2024.
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 0910-0442. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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.
Section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)) 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.
( printed page 84338)
In addition, applicable regulations in 21 CFR part 821 (21 CFR 821.1 through 821.60) 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 to the 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. We currently estimate 22,000 potential respondents.
In the
Federal Register
of August 8, 2023 (88 FR 53494), we published a 60-day notice soliciting 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
Activity; 21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Discontinuation of business—821.1(d)
1
1
1
1
1
Exemption or variance—821.2 and 821.30(e)
1
1
1
1
1
Notification of failure to comply—821.25(d)
1
1
1
1
1
Multiple distributor data—821.30(c)(2)
1
1
1
1
1
Total
4
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2—Estimated Annual Recordkeeping Burden 1
Activity; 21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours
Tracking information—821.25(a)
12
1
12
76
912
Record of tracking data—821.25(b)
12
46,260
555,120
1
555,120
Standard operating procedures—821.25(c) 2
12
1
12
63
756
Manufacturer data audit—821.25(c)(3)
12
1,124
13,488
1
13,488
Multiple distributor data and distributor tracking records—821.30(c)(2) and (d)
22,000
1
22,000
1
22,000
Total
592,276
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Acquisition of tracked devices and final distributor data—821.30(a) and (b)
22,000
1
22,000
1
22,000
Multiple distributor data and distributor tracking records—821.30(c)(2) and (d)
1,100
1
1,100
1
1,100
Total
23,100
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Upon evaluation of the information collection, we have made no adjustment to our currently approved burden estimate of 615,380 hours annually, based on 12 tracking orders. We attribute the attendant burden to the following activities:
Under § 821.25(a), 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, we estimate 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 § 821.25(d) manufacturers must notify FDA of distributor noncompliance with reporting requirements. Based on the number of audits manufacturers conduct annually, we estimate no more than one notice will be received in any year, and that it would take 1 hour per incident.
Under § 821.30(c)(2), multiple distributors must provide data on current users of tracked devices, current device locations, and other information, upon request from a manufacturer or FDA. Assuming one multiple distributor receives one request in a year from either a manufacturer or FDA, and that lists may be generated electronically, we estimate a burden of 1 hour to comply.
Under § 821.30(d) distributors must verify data or make required records available for auditing, if a manufacturer provides a written request. We assume 5 percent of tracked devices distributed for estimating burden. Each audited
( printed page 84339)
database entry prompts one distributor audit response. Because lists may be generated electronically, we estimate a burden of 1 hour to comply.
Use this for formal legal and research references to the published document.
88 FR 84337
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking,” thefederalregister.org (December 5, 2023), https://thefederalregister.org/documents/2023-26653/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-medical-d.