CDRH Releases FY 2027 Proposed Guidance List with Strong Focus on AI and 510(k) Reform The FDA’s Center for Devices and Radiological Health (CDRH) published its proposed CDRH guidance list for fiscal year 2027 on ... Read more October 8, 2026
FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the ... Read more June 18, 2026