FDA Sets Review Period for Impella Heart Device Patent

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2026-11966 — Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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: 2025-11025 — Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI

The FDA has officially set the review period for POMBILITI, a new human biological product. This means the company can apply to extend its patent, giving them more time to protect their invention. If approved, this could affect when generic versions hit the market and impact related business timelines and profits.

Next: 2025-11027 — Agency Information Collection Activities: Submission for OMB Review; Comment Requested; Passenger Vessel Operators

The Federal Maritime Commission is updating the paperwork rules for Passenger Vessel Operators, like ferry and cruise companies. They’ve asked the Office of Management and Budget to approve these changes and want the public to share their thoughts. This update aims to keep things smooth without adding extra costs or delays.