FDA Invites Comments on Third-Party Medical Device Review Data Practices
Published Date: 7/3/2025
Notice
Summary
The FDA wants your thoughts on how it collects info for the 510(k) Third-Party Review Program, which helps speed up medical device approvals. This affects companies making medical devices who use third-party reviewers. They’re asking for comments within 60 days, aiming to keep the process smooth without extra costs or delays.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
510(k) Third-Party Review Info Collection
If you make medical devices and use third-party reviewers, the FDA is asking for public comments for 60 days on the information it collects for the 510(k) Third-Party Review Program. The agency says this effort is meant to keep the review process running smoothly and avoid adding extra costs or delays for device makers.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11739 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
The FDA is officially putting simple COVID-19 rapid test devices into a safer, easier-to-manage category called Class II. This change means these tests can get to patients faster and with fewer hoops to jump through, while still making sure they work well and stay safe. Starting June 11, 2026, companies making these tests will follow new rules that help speed up innovation without extra costs.
2026-11740 — Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
The FDA is officially putting the Spinal Muscular Atrophy (SMA) newborn screening test into class II, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps make the test safer and easier to get to babies who need it, starting June 11, 2026, with the classification effective since November 2022. Labs and device makers will benefit from clearer rules and faster access, helping catch SMA early without extra costs or delays.
2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
The FDA is asking for approval to collect extra records from food businesses that handle certain high-risk foods. This helps track food sources quickly to keep everyone safe. Food companies should get ready to keep and share these new records, and comments on this plan are due by July 13, 2026.
2026-11762 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA is asking for approval to keep collecting info from seafood processors and importers to make sure fish products are safe using a system called HACCP. This affects anyone who processes or imports fish and requires them to keep records showing they’re following safety rules. Comments on this plan are open until July 13, 2026, and there’s no new cost, just a continuation of current paperwork.
2026-11589 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
The FDA has officially placed the combined acoustic and electrical external stimulation device for tinnitus relief into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to this innovative device faster and ensures it’s safe and effective. The new classification is effective June 10, 2026, with the rules applying retroactively from March 6, 2023.
2026-11578 — Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
The FDA just gave a thumbs-up to adding bemotrizinol as a new active ingredient in sunscreens, letting it be used up to 6% concentration. This means sunscreen makers can now include this ingredient, which is safe and effective, in their products. The change is official as of June 10, 2026, and could lead to better sun protection options without extra costs for consumers.
Previous / Next Documents
Previous: 2025-12415 — Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The FDA just got the green light from the Office of Management and Budget to keep collecting important info from businesses and the public. This means some forms and surveys will continue, helping the FDA keep food and medicine safe without extra costs or delays. If you’re involved with FDA rules, keep an eye out for these updates and deadlines!
Next: 2025-12417 — Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
The FDA wants your thoughts on a plan to quickly test how well their messages work. This affects anyone who helps or takes part in these quick surveys or tests. They’re asking for comments over the next 60 days and promise no big costs or hassles—just faster, smarter communication!