CDRH’s FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and AI By Steven J. Gonzalez & Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/10/cdrhs-fy-2027-proposed-guidances-shorter-lists-focused-on-software-and-ai/?utm_source=rss&utm_medium=rss&utm_campaign=cdrhs-fy-2027-proposed-guidances-shorter-lists-focused-on-software-and-ai FDA’s fiscal year (FY) 2027 began on October 1, 2026, at which time the Center for Devices and Radiological Health (CDRH) released its lists of proposed guidance documents it intends to publish or develop during the fiscal year, including: The A-list, which identifies guidance documents CDRH intends to publish. The B-list, which identifies the guidance documents CDRH intends to publish as resources permit. “Under Construction” list, which identifies guidance documents that CDRH intends to develop as resources permit.