FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar.

Below are a few important takeaways.

  • The presentation provided a high-level overview of the digital health space, the existing regulatory framework, and regulatory changes necessary under the 21st Century Cures Act.
  • For digital health products, FDA is moving away from the review of one product at a time toward a “reimagined approach” with marketing authorizations based on a developer’s culture of quality and organizational excellence.
  • The purpose of the pilot program is for FDA to learn about industry best practices (e.g., management, development, validation, deviation) and key performance indicators (KPIs) or other measures. These best practices and measures will inform the development of the future precertification program regulatory pathway.
  • Statements of Interest for participation in the pilot program should demonstrate that the participant is willing to share in the spirit of learning and make an impression that the company is excellent.
  • Participation in the pilot program does not protect a company from enforcement activities that result from a pilot site visit, but Bakul Patel stated that chosen participants will be “excellent” and, as an extension, presumably will not have compliance issues.

For more details about the Plan and pilot program, check out our latest article.

Details about the webinar, including the presentation slide deck, may be found here.

McDermott Will & Emery

Vernessa T. Pollard
Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety. Read Vernessa Pollard's full bio.




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