Die deutsche Medizintechnik-Industrie / SPECTARIS Jahrbuch 2021/2022

38 Gastbeitrag Looking Past the Pandemic in the United States: Medical Technology Into 2022 D espite the COVID-19 pandemic, United States rules and legislation surrounding medical technologies continue to evolve, proving the importance for device industry manufacturers to continue monitoring the legal landscape when marketing products in the United States (U.S.) This summary covers a selection of legislative and regulatory compliance developments to consider head- ing into the new year. » Encouraging Innovation Through the Safer Technologies Progra The U.S. Food and Drug Administration’s (FDA) existing Break- through Devices Program is intended to advance the development of innovative devices and help give patients more timely access to products that more effectively diagnose or treat life-threaten- ing or irreversibly debilitating conditions. On the other hand, the Safer Technologies Program (STeP), an idea introduced in the agency’s 2018 Medical Device Safety Action Plan, would provide an option for those devices with new advances/adaptations that could lead to a reduction in risk, but do not otherwise meet the criteria as a breakthrough device. STeP aims to encourage innovation and market entry of device technologies that are safer than current alternatives, thus im- proving patients’ quality of life and advancing the agency’s pub- lic health mission. Through this initiative, FDA plans to apply principles and features of the current Breakthrough Devices Pro- gram, to STeP, which would include devices with the potential for significant safety improvements instead for less serious con- ditions. These programs are intended to provide a more agile process for developers of breakthrough devices to obtain feedback through more frequent interactions with FDA during product development. This ultimately facilitates timelier premarket review and helps address the complexity and challenges of assessing highly novel breakthrough innovations. » Clarifying De Novo Classification Rule The FDA’s De Novo classification pathway, established in 1997, reduces regulatory burdens for manufacturers seeking approval to market their new low- to moderate-risk medical devices for which no predicate comparison device exists. Under this long Bethany Hills Partner, Morrison & Foerster LLP, Co-Chair, FDA and Life Science Compliance Practice, Editor, MoFo Life Science Blog, 250 West 55th Street, New York, mofo.com Internationale Märkte | Looking Past the Pandemic in the United States: Medical Technology Into 2022