Understanding The FDA's 510(K) Process: Lessons For UK Regulatory Reform
Topic : Regulation Type : Briefing
This document aims to help UK policy makers understand the United States Food and Drug Administration (FDA) 510(k) process. The purpose is to inform potential regulatory reliance or alignment between the UK and the US. As the UK reshapes its medical device regulations post-Brexit, evaluating how other established systems function is crucial. The 510(k) pathway, widely used in the US, is often misunderstood. This document addresses common misconceptions and explains how the pathway works in practice. Understanding the strengths and limitations of the 510(k) model may support decisions about international recognition or regulatory cooperation. Regulatory models that reflect the distinct nature of medical devices and IVDs, ensure that international recognition supports both access and adoption.