Silver Spring, August, 2017.  FDA Commissioner Scott Gottlieb announced earlier this month as part of the Digital Health Innovation Action Plan that the pilot program allowing lower risk mobile medical apps to be marketed via third-party certifications is now formally underway.

Attempting to appeal to both digital health product developers large and small, Dr. Gottlieb indicated FDA left the inclusion criteria rather broad to be selected for the Pilot:

  • The company must be in the process of developing or planning to develop a software product that meets the definition of a medical device;
  • The company must have an existing track record in developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence measures that are tracked by Key Performance Indicators (KPI) or other similar measures;
  • And during participation of the pilot, companies must agree to:
    • Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
    • Collect real-world post-market data and provide it to FDA;
    • Meet with FDA for real-time consultation;
    • Be available for site visits from FDA officials; and,
    • Provide information about the firm’s quality management system.

According to Dr. Gottlieb, “companies can submit a statement of interest that includes the qualities listed above, requesting participation in the pilot to FDAPre-CertPilot@fda.hhs.gov. Then, during the month of August, FDA’s Digital Health Team will evaluate submissions and select companies that reflect the broad range of software developers. A critical component is that we will include small and large companies, traditional and non-traditional medtech companies, and products that range in risk. This approach will create opportunities for more dynamic entrepreneurship and competition and help continue to drive product innovation.”

Are you interested, but have a few questions?  FDA has a FAQs page that may address yours here.

Did you know The CRO Group is a market leader in supporting both FDA and international regulatory needs of mobile medical app startups and SaMD developers?  Primary to that support is setting up high quality software design, verification and validation, and the design control documentation without slowing down Agile/SCRUM development., so both 510(k) premarket submissions as well as European technical files projects complete on time.  For more information as well as a no cost no obligation introductory meeting on how The CRO Group can assist from Boston to Silicon Valley to Shenzhen, China, click here or,

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