Why did the Number of US FDA Medical Device Guidelines Begin to Rise in the Mid-2010s? A Perspective

Introduction: In the US, the FDA regulates medical devices (MDs), a large and diverse group of medical products. In 2020 alone, there were at least 5000 novel MDs registered as compared with the few hundred medicines. It is speculated that intrinsic forces, such as FDA guidelines, may have affected MD productivity. Areas Covered: An initial investigation of US MD guidelines is presented, with the aid of those of medicines. It is found that since the first recorded FDA MD guideline (February 1975) until the mid-2010s, the number of MD guidelines has been basically stable, then rapidly rose. Expert Opinion: The rise of the COVID-19 pandemic and digital health technologies explains 50% of this upward momentum. During this period, it is also found that MD and medicinal guideline evolution is now moderately correlated from historical ‘acorrelatedness.’ This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of ‘innovation saltus’ – periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science;viz., examination of guidelines (as proxy measures of regulations) and their influence on innovation.