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Volume XI, Number 339


December 03, 2021

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FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches

FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act and describe which digital health technologies FDA will regulate as “devices.”

Our alert discusses key takeaways from the draft guidances and implications for digital health technologies, including clinical decision support and patient decision support software, technologies that incorporate machine learning or AI, and digital health products marketed by pharmaceutical companies.

Here are a few noteworthy items from the draft guidance documents:

  • Under FDA’s initial interpretation of the Cures Act, many clinical decision support (CDS) software functions could remain subject to FDA regulation.
  • Dynamic digital health solutions, such as those that incorporate machine learning or artificial intelligence (AI), are not directly addressed in the drafts.
  • FDA has proposed an enforcement discretion approach for decision support software aimed at patients, even though patient decision software (PDS) was not addressed directly in the Cures Act.
  • Consistent with the Cures Act, many software functions that were previously subject to FDA enforcement discretion (i.e., not actively regulated as devices) no longer meet the definition of “device.”
  • Pharmaceutical companies should note that CDER joined one of the draft guidances, which states that FDA requirements beyond those outlined in the draft guidance may apply to digital health products disseminated by or on behalf of a drug sponsor.
  • FDA indicates that its regulatory oversight of CDS software that analyzes physiological signals to provide diagnostic, prognostic and predictive functionalities could include algorithms that analyze and interpret genomic variations to determine a patient’s risk for a particular disease.

As discussed in our alert, companies who are marketing or developing digital health products should assess how FDA’s proposed policies may impact their product portfolio and consider submitting comments on the draft guidances.  The FDA docket is open for comments until February 6, 2018.

© 2021 Covington & Burling LLPNational Law Review, Volume VII, Number 355

About this Author

Christina Kuhn, Covington, Food and drug lawyer

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy...