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Updated regulations on FDA acceptance of medical device clinical data in effect soon

  • Posted by: inetika
  • Category: COMPANY NEWS

On 21 February 2018, FDA published a final rule1 updating its regulations on the acceptance of clinical data generated outside or inside the United States (US), which are intended to support any type of medical device FDA application or submission. A previous article discussed the proposed rule .

This article will provide an overview of the updated regulations and a related guidance document published on the same date as the final rule.
Maria E. Donawa, M.D.

To see the full article PDF format click here 

 

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