San Jose, September, 2017.  Out of over 100 applicants, FDA Commissioner Gottlieb chose AdvaMed’s MedTech conference in San Jose last week to announce the nine companies selected for FDA’s precertification pilot for digital health applications.

While many companies selected for the pilot are well-known large corporations, there are a few small startups.  All are well-known in the digital health sector :

  • Apple, Cupertino, California
  • Fitbit, San Francisco, California
  • Johnson & Johnson, New Brunswick, New Jersey
  • Pear Therapeutics, Boston, Massachusetts
  • Phosphorus, New York, New York
  • Roche, Basel, Switzerland
  • Samsung, Seoul, South Korea
  • Tidepool, Palo Alto, California
  • Verily, Mountain View, California

Only time will tell if FDA will take due advantage of the collaboration with these ‘lucky nine’ and if the proposed result –  guidelines for other digital health companies for FDA precertification can be reached with less documentation and submissions than that currently required for premarket approval.  Under the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system. This sharing will help the FDA continue to build its expertise in these areas, while giving the agency the information it needs to provide proper oversight of these products and firms.  Exactly how much access by these companies, particularly those with popular consumer products who have ultra-proprietary development practices, remains to be seen.  In the announcement, FDA advised of the Pre-Cert Digital Health Webpage where those in the space should be able to get updates as the program evolves.

You can review Dr. Gottlieb’s announcement here or, if you would like to discuss your digital health and or wearable product and how CRO Group may be of assistance and accelerate development conforming to FDA Guidelines and IEC 62304 AND within AGILE,  SCRUM, or KANBAN models, or, to receive more updates like this one, and possibly



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