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Webinar: FDA Refuse to Accept RTA Guidance for Premarket Submissions

Topics:
Regulatory, FDA readniess, Thought leadership
Webinar: FDA Refuse to Accept RTA Guidance for Premarket Submissions
Webinar: FDA Refuse to Accept RTA Guidance for Premarket Submissions
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April 11, 2023
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In this webinar, MedCrypt CEO Mike Kijewski and FDA expert Naomi Schwartz share their thoughts on the FDA's new Refuse to Accept (RTA) guidance. In March 2023, following the December 2022 Omnibus bill passed by Congress, the FDA released its RTA Cybersecurity guidance. This stipulated that after October 2023, any medical device manufacturer that fails to meet specific cybersecurity rules would have its products rejected by the FDA.


Speakers

Our team of FDA analysts and  cybersecurity experts provide robust and actionable cybersecurity roadmaps to ensure you meet FDA requirements. Get the Medcrypt advantage today!

Naomi Schwartz

Naomi Schwartz

Sr Director of Cybersecurity Quality and Safety
Mike Kijewski

Mike Kijewski

CEO

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