Advancing digital health technologies is one of FDA’s strategic priorities for 2018.  FDA’s Center for Devices and Radiological Health (CDRH) has traditionally taken a leading role in establishing FDA’s regulatory policies toward digital health technologies, and recent FDA announcements on digital health indicate that CDRH will continue efforts to develop new agency approaches toward digital health.  In a recent post on our Digital Health blog, Covington’s Digital Health team described the FDA’s latest announcements. Key updates include:

• Expansion and Public Input on the Pre-Certification Pilot Program: FDA took another step in developing the novel model for pre-market review of software devices and released a draft working model for the Pre-Certification program. FDA requests comments to the working model by May 31, 2018.

• New Framework for FDA’s Approach to Artificial Intelligence: Commissioner Gottlieb announced that FDA was “actively developing a new regulatory framework to promote innovation . . . and support the use of AI-based technologies.” This includes applying the Pre-Certification program in a way that accounts for the ability of machine learning-based technologies to improve over time and ensuring that other aspects of the regulatory framework, “such as new software validation tools, are sufficiently flexible to keep pace with the unique attributes of this rapidly advancing field.”

• Continued FDA Guidance Implementing the Cures Act: Multiple Functions Guidance: Pursuant to the agency’s Digital Health Innovation Action Plan, FDA issued a draft guidance, “Multiple Function Device Products: Policy Considerations,” addressing products that contain multiple functions, some of which are subject to FDA regulatory oversight as medical devices and others of which are not. The 21st Century Cures Act outlined a function-by-function approach to determining appropriate FDA regulation of health and medical software, and the Cures Act permits FDA to regulate only those software functions that meet the definition of a device, although the agency may consider the impact of the non-device software functions on the regulated device functions. Stakeholders can submit comments on the draft guidance in the electronic docket through June 26, 2018.

• Launch of New FDA Program to Apply Digital Health to Drugs: Commissioner Gottlieb recognized the regulatory uncertainty around digital health associated with pharmaceuticals and announced that FDA will seek public input “on the right approach to incorporating software that’s designed to be used with prescription drugs” and “expand the opportunities to use digital health tools as part of drug development.”

• New Digital Safety Reporting for Drug and Biologic Clinical Trials: FDA will implement a new program to enable a unified data standard for meeting electronic reporting requirements under the expedited safety-reporting regulations of an Investigational New Drug application (IND).

• New Digital Health Incubator at FDA – INFORMED: The agency is creating an internal data science incubator called the Information Exchange and Data Transformation, or INFORMED. Launched in collaboration with HHS Innovation, Design, Entrepreneurship and Action (IDEA) Lab, the incubator will focus on the “conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer” to help modernize the framework for “advancing promising digital health tools.”