EUA and the Impending Transition

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There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it.

Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services.

Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.

Some of the highlights of today’s show include:

  • Whether there’s an EUA transition deadline yet
  • What EUA companies need to be doing right now on the quality side of things
  • What the EUA transition will look like
  • How adverse events need to be documented
  • The potential for the EUA as the norm in certain situations
  • What to focus on for companies that started with a non-med device then got into the EUA
  • What happens if you go past the 180 days

Memorable quotes from Kyle Rose:

"This is going to end, and companies have to figure out what to do to go back to their traditional regulatory path for their device or their expansion of labeling and use to maintain compliance."

"You need to start working on this before phase three."

"From phase one to phase two is 90, from phase two to phase three is 90, and then phase three it says 180 days after implementation."

"If you’re going to build your quality system, I would definitely say you can apply with both FDA and ISO."

“If you have submitted, and it goes past the 180 deadline into phase three, you’re still able to sell as long as you’re under review."

Links

Rook Quality System

Kyle Rose

FDA Guidance Document

FDA Webinar Slides

Etienne Nichols LinkedIn

etienne.nichols@greenlight.guru

MedTech Nation

GG Academy

Greenlight Guru

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