#476: Part 2: FDA Guidance: What We Should Expect in 2027

What this episode covers

Regulatory consultant Michael Drues, Ph.D., joins host Etienne Nichols to analyze the FDA's Center for Devices and Radiological Health (CDRH) guidance priorities for fiscal year 2027, covering the A-list, B-list, and under-construction categories. Drues critiques the agency's use of vague language like "intends to publish" and "resources permit," noting that only 63% of previous guidance documents were actually released, and questions why B-list items like cybersecurity are prioritized over A-list topics. The discussion highlights the distinction between wellness devices and those with medical purposes, the iterative nature of regulation, and the potential risks of relying on AI for both submission writing and review.