Medical Product Development Part 2: Patent and FDA Issues.

Nadeem, Maheen; Weiss, Arnold-Peter C · J Hand Surg Am · 2021

review · Level V

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Abstract

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.

Medical subject headings