Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the ...
The Food and Drug Administration (FDA, Agency, or we) 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 information collection requirements for the tracking of medical devices.
DATES:
Either electronic or written comments on the collection of information must be submitted by November 10, 2026.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 10, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to
www.regulations.gov
will be posted to the docket unchanged. Because your
( printed page 57894)
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
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”).
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-2026-N-9350 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking.” Received comments, 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
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 onwww.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:
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
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 Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
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.
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. 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.
FDA estimates the burden of this collection of information as follows:
( printed page 57895)
Table 1—Estimated Annual Reporting Burden
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)
2
2
4
1
4
Multiple distributor data—821.30(c)(2)
1
1
1
1
1
Total
7
Table 2—Estimated Annual Recordkeeping Burden
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)
13
1
13
76
988
Record of tracking data—821.25(b)
13
46,260
601,380
1
601,380
Standard operating procedures—821.25(c) 1
13
1
13
63
819
Manufacturer data audit—821.25(c)(3)
13
1,124
14,612
1
14,612
Multiple distributor data and distributor tracking records—821.30(c)(2) and (d)
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
Our estimated burden for the information collection reflects an overall increase of 47,526 hours and a corresponding increase of 47,389 responses/records. We attribute this adjustment to an increase in the number of submissions we received over the last few years.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
www.regulations.gov
21 CFR 10.20
www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf