FDA seeks comments on device tracking paperwork
Published Date: 9/11/2026
Notice
Summary
The FDA wants your thoughts on how they collect info to track medical devices. This affects companies that make or handle these devices and aims to keep things safe and clear. You’ve got until November 10, 2026, to share your comments—no cost, just your voice!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Tracking Rules Create Reporting Burden
If you make, import, or distribute tracked medical devices (class II or III devices that fail could cause serious harm, implants in the body for more than 1 year, or life‑sustaining devices used outside a device user facility), you are a respondent under 21 CFR part 821. FDA estimates about 22,000 potential respondents and total annual recordkeeping burden of 639,799 hours, plus 23,100 annual third‑party disclosure actions; FDA also reports an overall increase of 47,526 hours and 47,389 responses/records.
Tracking Data Speeds Recalls and Notices
FDA collects tracking information so manufacturers and the Agency can find where tracked devices and patients are and use that data to speed recalls and notify patients or licensed practitioners about risks associated with those medical devices.
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Key Dates
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