The last decade has seen dramatic growth in the development and proliferation of digital health software. This growth coupled with the changing technology landscape and the influx of new industry stakeholders has driven FDA to adapt its thinking about the medical device regulatory framework and its application to “software as a medical device” or SaMD products. FDA has taken an increasingly de-regulatory approach and is shifting to a new paradigm, the basis of which involves promoting innovation and rapid commercialization of SaMD by reducing pre-market regulatory burden while protecting the public health by increasing post-market oversight. In particular, FDA has recently published guidance on its regulatory policy for digital health software (including mobile medical apps), clinical decision support software, and software products that contain regulated and unregulated functionality, including the formal adoption and implementation of the International Medical Device Regulators Forum risk categorization scheme. In addition, FDA has embarked on the development of a regulatory policy for artificial intelligence and a new “pre-certification” model of software oversight. This session will 1) describe the evolution of FDA’s regulatory approach to digital health software; 2) discuss the opportunities, concerns, and uncertainties from the perspective of small digital health software developers, and 3) share insights into expected near-term policy changes. This session will appeal to a broad range of attendees—from regulators to software developers. For regulators, this session will allow small digital health software developers to share their perspective on recent, proposed, and anticipated regulatory changes. The feedback can shed light on the impact of regulatory policies on the largest segment of the digital health industry, providing a voice to many who often lack the opportunity to engage with regulators. For software developers, the session provides a discussion of the new regulatory policies that have a tangible impact on their businesses.
Demonstrate an understanding of the evolution of the FDA’s regulatory approach to digital health software.
Describe the opportunities, concerns, and uncertainties associated with the regulatory framework for digital health software.
Describe anticipated near-term policy changes related to digital health software.