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.
Specifically this webinar will cover:
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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
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In parallel to EUA, a “normal” FDA submission should be prepared and submitted under 510(k), PMA, or other regulatory approval pathways
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Assessing the design and development approach used for an EUA-approved device will identify gaps to be addressed to prepare a “normal” submission
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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
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Q&A session
Who should attend?
- Product Development Engineers and Management
- R&D Engineers and Management
- Quality Professionals and Management
- Medical Device Executives
