FDA Releases Software Tips for Safer Medical Devices

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: 2025-18465 — Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Partially Closed Meeting

The Eunice Kennedy Shriver National Institute of Child Health & Human Development is holding a two-day virtual meeting on January 26-27, 2026. The first day is open to the public and will share updates and scientific talks, while the second day is closed to review grant applications confidentially. Researchers and the public can join or send comments, with no cost to attend and easy online access.

Next: 2025-18470 — New Functionality Pertaining to Electronic Refunds in the Automated Commercial Environment

U.S. Customs and Border Protection is making it easier for businesses to get electronic refunds by adding a new ACH Refund Authorization tab in the ACE Portal. This means faster, smoother refunds through Automated Clearinghouse (ACH) payments. If you import goods, get ready to save time and possibly speed up your money back starting soon!