FDA Keeps Tabs on Device Safety After Sales
Published Date: 12/23/2025
Notice
Summary
The FDA is asking for approval to keep collecting info from medical device makers about how their products perform after they hit the market. This helps keep devices safe and effective for everyone. If you’re a manufacturer, get ready to submit reports and plans by January 21, 2026, with no new fees involved.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Manufacturers Face Multi‑Thousand Hour Reporting Burden
If you are a medical device manufacturer required to do postmarket surveillance under 21 CFR part 822, the FDA estimates an annual reporting burden of 4,968 hours for submissions and reports. The largest item is periodic reports (Sec. 822.38) estimated at 4,200 hours from 35 respondents (3 responses each, 40 hours per response); FDA also reports an increase of 1,890 burden hours and 45 annual responses based on internal tracking.
No Capital or Operating Costs Required
The FDA states there are no capital costs or operating and maintenance costs associated with this information collection (OMB Control Number 0910-0449). You will not face new capital or O&M fees tied to this paperwork collection.
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