Hardware Podcasts

EUA and the Impending Transition

Global Medical Device Podcast · 26 Oct 2022 · 40m · Episode 286

What this episode covers

Kyle Rose, President of RookQS, explains the FDA's phased transition away from Emergency Use Authorizations (EUA) for medical devices, detailing the 180-day timeline and the specific compliance requirements for each phase. He highlights that many companies, including non-medical manufacturers and academic labs, entered the market during the pandemic with significant gaps in their Design History Files (DHF) and Quality Management Systems (QMS). Rose advises these companies to immediately begin preparing for traditional regulatory pathways, such as 510(k) or De Novo submissions, and to implement robust adverse event reporting and Unique Device Identification (UDI) systems before the final phase deadline.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
RookQS, Greenlight Guru
Also
FDA, ISO 13485, 510(k), De Novo, UDI

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