Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway

Collaborative Communities: Addressing Healthcare Challenges Together Webinar: Collaborative Communities – October 29, 2019 FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working to develop solutions to medical device innovation challenges Framework for the Safety and Performance Based Pathway Webinar – Safety and Performance Based Pathway Performance Criteria – November 7, 2019 Safety […]

Several revised or updates USFDA guidance

9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 – The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 – The Special 510(k) Program: Guidance for Industry and Food and Drug […]

How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities

So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to perform a clinical evaluation. I notice that a lot of people does not seem to not that a clinical evaluation is nothing more than a specific application of a systematic […]