June 5, 2026
The FDA released a new final guidance yesterday titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” A total of 13 product codes across 8 FDA review divisions were listed in the guidance that will…Read More
January 7, 2026
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
September 28, 2023
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
