Understanding The FDA's 510(K) Process: Lessons For UK Regulatory Reform
Topic : Type : Briefing
This latest paper examines the FDA’s 510(k) medical device clearance process.
Created in collaboration with leading experts in US regulation, it aims to dispel common myths surrounding the 510(k) pathway, highlighting its structured review process and robust post-market requirements. It also offers valuable insights to inform UK regulatory reform, supporting risk-based oversight, international alignment, and future pathways for global cooperation.
Download it via the link below.