The first FDA Town Hall Road Show Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review was a fantastic event! What an honor to host two key leaders from FDA CDRH - Jianchao Zeng and Patrick Axtell! The work they are doing through several innovative tools to streamline the review process (e.g., Declarations of Conformity, ASCA, and eSTAR) is incredible. Huge thanks to both of them for sharing their passion and engaging in such open, interactive discussion with the full house! Huge thanks as well to our Regulatory Affairs Professionals Society (RAPS) Chapter event sponsor and host site Boston Scientific!! A couple of tips for other Chapter leaders who will be hosting this road show in the future: 1) Despite the direct FDA communications and fantastic content, this event took A LOT of marketing to get the attendance numbers up - don't underestimate the number of social media communications that will be needed, 2) strongly recommend requesting Patrick Axtell or a member of his team participate in addition to the standards representative(s) - there is a significant amount of content related to eSTAR submissions, and having the developer there to discuss and answer questions was invaluable!!
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Lisa Pritchard
VP of Regulatory, Quality, Clinical and Engineering
DuVal & Associates PA
Bloomington MN
United States
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