Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
未经批准：在美国（美国），FDA监管医疗器械，大量多样化的医疗产品。仅在2020年，与几百种药品相比，至少有5000种新型医疗器械注册。据推测，内在力量，如FDA指南，可能会影响医疗器械的生产率。
未经评估：对美国医疗器械指南进行了初步调查，借助那些药物作为定性比较。自第一个记录FDA医疗器械指南（1975年2月）到2010年代中期，医疗器械指南数量基本稳定，然后迅速上升。
未经评估：COVID-19大流行和数字健康技术的兴起解释了自2010年代中期以来指南中50％的上升势头。同时，医疗器械和药物指南变得中度相关。这种观点认为，这种趋势将持续下去，而不管流行病的消退如何，因为它嵌入了“创新盐”的概念-即，离散的高度创新时期。这项工作的一个关键愿望是激发对监管科学这一有趣领域的更多研究；即。,审查准则(作为法规的替代措施)及其对创新的影响。
未经评估：对美国医疗器械指南进行了初步调查，借助那些药物作为定性比较。自第一个记录FDA医疗器械指南（1975年2月）到2010年代中期，医疗器械指南数量基本稳定，然后迅速上升。
未经评估：COVID-19大流行和数字健康技术的兴起解释了自2010年代中期以来指南中50％的上升势头。同时，医疗器械和药物指南变得中度相关。这种观点认为，这种趋势将持续下去，而不管流行病的消退如何，因为它嵌入了“创新盐”的概念-即，离散的高度创新时期。这项工作的一个关键愿望是激发对监管科学这一有趣领域的更多研究；即。,审查准则(作为法规的替代措施)及其对创新的影响。
