Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective.

Abstract

An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical device guidelines has been basically stable, then rapidly rose. The rise of the COVID-19 pandemic and digital health technologies explains 50% of the upward momentum in guidelines since the mid-2010s. Concomitantly, medical device and medicinal guideline