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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20503, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
The FDA fixed a previous announcement about Oxandrin tablets (2.5 mg and 10 mg) being pulled from the market due to safety or effectiveness concerns. This update confirms that not only the original drug but also several generic versions were withdrawn and removed from the official drug list. Patients, doctors, and drug makers should note these changes, which affect availability and prescribing options immediately.
Previous / Next Documents
Previous: 2025-23631, Submission for OMB Review; Comment Request
The Department of Agriculture is asking for public feedback on how it collects info about lottery and gambling winnings for SNAP benefits. If you or your household get big lottery or gambling money, you must report it to keep getting food help. Comments are open until January 21, 2026, so now’s the time to speak up and help make the process easier and clearer!
Next: 2025-23632, Privacy Act of 1974; Matching Program
The Department of Education and the IRS are teaming up again to share info that helps decide who qualifies for student loan repayment plans and federal financial aid like Pell Grants. This matching program kicks off around January 30, 2026, and runs for 18 months, with a chance to extend. It’s all about making sure aid and repayments are fair and accurate, with no extra cost to you!