During the pandemic the FDA has approved over 70 medical devices, so far, for use to diagnose or treat COVID-19. The EUA regulatory approval pathway requires that minimal supporting documentation be submitted to receive approval. The EUA approval is a temporary approval and authorization for use of devices approved under the EUA will end in the (relatively) near future. In this session RND Group will describe activities companies need to be doing now to prepare and submit their device for approval through non-EUA regulatory pathways to ensure their device can remain on the market after EUA approval expires.
Talk Takeaways: • EUA approval is truly temporary and once EUA approval expires, a product must be removed from the market if it is not otherwise approved or cleared
• In parallel to EUA, a “normal” FDA submission should be prepared and submitted under 510(k), PMA, or other regulatory approval pathway
• Assessing the design and development approach used for an EUA-approved device will identify gaps to be addressed to prepare a “normal” submission
• Companies without prior successful FDA submission experience are most at risk for not being prepared and for not receiving a timely approval of a follow-up submission after their EUA expires
ABOUT RND GROUP:
RND Group was founded in 1997 and has assisted medical device companies in the release of over 50 FDA approved products. RND Group is a full-service company for regulated products that provides software development, software verification, software validation, and technical and regulatory consulting services. Our customers range from startups to Fortune 50 companies – anyone who needs assistance in getting regulated software development done correctly the first time. We have experience in a wide variety of technologies – from firmware, to stand-alone devices on real-time / Linux / Windows, to cloud-based systems on AWS / Azure / Google Cloud, to Next Generation Sequencing applications. We can be your software development team, regulatory consulting experts, or can augment your existing team with experienced regulated software developers and testers.