Medical Product Development Part 2: Patent and FDA Issues.

J Hand Surg Am · Aug 19 2021 · Review

Nadeem M, Weiss AC

Department of Orthopaedics, Warren Alpert Medical School of Brown University, Providence

General Orthopaedics

SUMMARY — THE REDUCTIONSecond installment of a series guiding surgeons through medical device development, focusing on the patent application process and FDA approval requirements before market entry.
Abstract, as published

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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