Medical Product Development Part 2: Patent and FDA Issues.

J Hand Surg Am

Department of Orthopaedics, Warren Alpert Medical School of Brown University, Providence, USA. Electronic address:

Published: October 2021

In part 2 of this review series on how to engage with the medical device industry as a surgeon, we summarize the patent application process. The federal government must approve any invention you might try to bring to market as safe-to-use for patients before any marketing can be initiated via the Food and Drug Administration submission process detailed herein.

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http://dx.doi.org/10.1016/j.jhsa.2021.07.011DOI Listing

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