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  • You could reach out to Gerry O'Dell ( https://www.linkedin.com/in/gerry-o-dell-ba58834/ ) ------------------------------ George Tiller Los Angeles CA United States ------------------------------

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    Does IVD EUA require Design Control 820.30?

    This message was posted by a user wishing to remain anonymous Hello, I have read several of the FDAs guidance on the EUA authority and process, but I need help finding an answer. Does an IVD that is developed and submitted (or intended to be submitted) require compliance to 21 CFR part 820, specifically Design Control 820.30? I found that FDA has ...

  • Hi Joshua, I've done several Class II licenses recently and I agree with the other members - they're very quick to review and issue licenses, provided the application is complete.  In my experience, the applications are reviewed and approved within their performance target timeframes (around 15 days). One spot where I've seen hangups occur is in ...

  • I agree with Richard, Salman and Victor on this issue. It has to be PRRC and has to be on job.  It's not like other business agreements.. If a CEO leaves a company it's a major change to your organizational structure, then if he was signing the DoC too so it's also affecting your products and processes. The change must have been reported in your management ...

  • Hi Shikha, The session will take place on this thread on RegEx! Pete and Herb will respond to questions posted to the thread tomorrow from  1:30-2:30 PM ET. Best, Annie ------------------------------ Annie O'Brien Community Manager Regulatory Affairs Professional Society regex@raps.org ------------------------------

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Volunteer Appreciation 2020

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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