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Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform.
As President-elect Joseph Biden gears up to take office on January 20, the upcoming change in administration will impact the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared