De Novo Classification Process in the Final Rule Stage

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The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the De Novo . . .

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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