I learned a long time ago to keep tabs on FDA import alerts, which names firms that have been deemed by FDA to be violative of import requirements for a whole host of reasons. Once on the list,…Read More
August 10, 2026
Contact Us
News
Category: Enforcement Discretion
March 12, 2026
FDA holds virtual Town Hall meeting on Clinical Decision Support guidance update
The FDA held a virtual town hall on March 11th, 2026 on the Clinical Decision Support (CDS) Software guidance update, which published on January 6th, 2026 and republished on January 29, 2026. This was an eagerly awaited event to…Read More
February 12, 2026
FDA holds virtual Town Hall meeting on recent General Wellness guidance update
The FDA held a virtual town hall today (February 11th, 2026) on the General Wellness guidance update which published on January 6th, 2026. This was a highly anticipated event to address questions on the guidance, which was reported…Read More
January 7, 2026
FDA releases update to Clinical Decision Support Software guidance that expands non–regulated opportunities for AI industry
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
January 6, 2026
FDA releases update to General Wellness guidance that creates new opportunities for industry to operate without FDA regulation
The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this…Read More
December 9, 2025
Industry players request that FDA Center for Devices and Radiological Health (CDRH) withdraw certain guidances and prioritize other guidances in fiscal year 2026
The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More
September 29, 2023
Late Breaking News: FDA Issues Proposed Rule on Laboratory Developed Tests (LDTs), Outlines Plans for Greater Oversight of LDTs and Eventual Phaseout of Enforcement Discretion Approach to LDTs
It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
