COVID Shots Get 2025 Makeover: FDA Asks for Public Input

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2026-11966 — Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability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

2026-11739 — 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.

Previous: 2025-08082 — Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

Some folks want to buy shares in banks or bank companies, and the Federal Reserve is checking their applications to make sure everything’s fair and safe. If you want to share your thoughts, you’ve got until May 23, 2025, to speak up! This process helps keep banks strong and protects your money.

Next: 2025-08085 — Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; NESHAP for Plating and Polishing Area Sources (Renewal)

The EPA is asking to keep collecting info from businesses that do plating and polishing to make sure they follow pollution rules. This renewal keeps things running smoothly without adding new costs or big changes. If you’re involved in these industries, now’s the time to share your thoughts before the deadline!