June 17, 2019

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FDA Outlines 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.

© 2019 McDermott Will & Emery


About this Author

Vernessa Pollard Pharmaceutical Attorney McDermott

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...