Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect 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 for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.
During the Trump administration, FDA continued to move forward in developing new guidance documents and policies for digital health, including guidance documents to implement the software exemptions under the 2016 21st Century Cures Act and COVID-19 digital health guidance documents. In addition, FDA continued to move forward with its pilot program for Software Precertification and established a new Digital Health Center of Excellence.
However, FDA has yet to issue its much-anticipated final guidance for Clinical Decision Support (CDS) software, after revamping its draft CDS guidance in September 2019. FDA also has not yet finalized its updated guidance document on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued in draft format in October 2018). We expect FDA’s efforts on these digital health issues to continue under the incoming Biden administration.