FDA Revamps Rules to Stop Infections from Body Part Swaps

2026-12167 — Andrew Jonathan Morgan: Final Debarment Order

Andrew Jonathan Morgan is officially banned for 5 years from importing any drugs into the U.S. because he was convicted of a serious crime related to drug importation. He didn’t respond to the FDA’s notice, so the ban started on June 17, 2026, and he can apply to end it anytime. This means no drug imports from him for a while, keeping things safe and legal.

2026-12165 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule

The FDA is officially putting the ingestible gastrointestinal blood detection capsule into Class II, meaning it now has special safety rules but fewer hurdles than before. This change helps patients get access to this cool, innovative device faster and keeps it safe and effective. The new classification is effective June 17, 2026, and could save time and money for makers and users alike.

2026-12166 — Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan

The FDA is officially putting radiology software that uses machine learning and has a set plan for updates into a safer, easier-to-manage category called Class II. This change helps make sure the software is safe and effective while speeding up patient access to cool new tech. It’s been effective since early 2023, so companies can expect fewer hoops to jump through without extra costs or delays.

2026-11966 — Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

The FDA just dropped a draft guide to help businesses fill out Forms FDA 3542a and FDA 3542 without confusion. If you submit these forms, this guide answers your top questions and makes the process smoother. You’ve got until August 14, 2026, to send in your feedback before the FDA finalizes the guide—no extra costs, just clearer steps!

2026-11998 — Amendment and Revocation of Organizational Information Regulations

The FDA is updating its rules to point everyone to its website for the latest contact and organizational info, ditching old, unnecessary regulations. This makes it easier for the public to find accurate info all in one place, starting June 15, 2026. If you interact with the FDA, expect smoother access with no 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.

Previous: 2025-07751 — Norfolk Southern Railway Company-Trackage Rights Exemption-CSX Transportation, Inc.

Norfolk Southern Railway (NSR) got special permission to use CSX Transportation’s tracks for about 95 miles to reroute trains while a tunnel in Baltimore is being fixed. Now, NSR and CSX have agreed to end this temporary track-sharing deal once the project is done, and the Surface Transportation Board is approving that plan. This means NSR won’t need extra approvals later, keeping things smooth and simple for everyone involved.

Next: 2025-07754 — Foreign-Trade Zone (FTZ) 102, Notification of Proposed Production Activity; Tight Line Composites LLC; (Carbon Fiber Profiles for Wind Turbine Spar Caps); Earth City, Missouri

Tight Line Composites in Earth City, Missouri, wants to make carbon fiber parts for wind turbines inside a special Foreign-Trade Zone (FTZ 102). This lets them use certain imported materials with lower or no import taxes, saving money and speeding up production. Public comments are open until June 16, 2025, before the government gives the final thumbs-up.