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

Abstract

ABSTRACT In the United States (US), the FDA regulates medical devices, a large and diverse group of medical products. In 2020 alone, there were at least 5000 novel medical devices registered as compared with the few hundred medicines. It is speculated that intrinsic forces, such as FDA guidelines, may have affected medical device productivity. Areas Covered 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. Expert Opinion 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 guidelines became moderately correlated. This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of ‘innovation saltus’ – i.e. discrete periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science; namely, examination of guidelines (as proxy measures of regulations) and their influence on innovation.