Do you have a medical device on the market through the FDA's EUA regulatory approval pathway? How can you ensure your device can remain on the market after the EUA approval expires? Watch now to learn what you need to be doing now to prepare and submit your device for approval through non-EUA regulatory pathways.
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.
Because of this, 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 video Brad Graves, Principal/Project Leader, and his colleague Cathy Wilburn, Director of QA & Compliance, from the RND Group explain the activities companies with EUA devices must do now to prepare for a "normal" FDA submission under 510(k), PMA, or another regulatory approval pathway.
★ KEY VIDEO TAKEAWAY★
- 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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This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:
1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic
The video you’re watching now is from our GROW Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: • The Greenlight Guru Tr...
Plus, download the slides from this presentation for free here: www.slideshare.net/greenlight...
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