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FDA’s List of “Digital Health” Companies Destined for Precertification Includes Verily, Which Hired Former FDA Commissioner Califf!

FDA’s List of “Digital Health” Companies Destined for Precertification Includes Verily, Which Hired Former FDA Commissioner Califf! | Pharma Industry Regulation | Scoop.it

The FDA has issued the names of the companies selected for the first wave of the pilot program. The nine participants include medical device and health technology innovators. The scheme is called the FDA’s digital health software precertification pilot program. This is part of the agency’s Digital Health Innovation Action Plan, which, in turn, derives from federal legislation passed in 2016 (21st Century Cures).

 

The announcements were made by U.S. FDA Commissioner Dr. Scott Gottlieb at the AdvaMed MedTech Conference, which took place in San Jose, California in January 2018. The program, according to Gottlieb, is focused on evaluating the robustness of each company rather than the products they produce.

 

The companies, drawn from over 100 applicants, in the first tranche are:

 

  1. Apple, Cupertino, California,
  2. Fitbit, San Francisco, California,
  3. Johnson & Johnson, New Brunswick, New Jersey,
  4. Pear Therapeutics, Boston, Massachusetts,
  5. Phosphorus, New York, New York,
  6. Roche, Basel, Switzerland,
  7. Samsung, Seoul, South Korea,
  8. Tidepool, Palo Alto, California,
  9. Verily, Mountain View, Califo.

 

As part of the scheme, each company agreed to be available for site visits from FDA staff, and to submit documented evidence concerning their quality management system.

 

Related Reading:

 

  • “FDA Looking for a Few Good Digital Health Product Developers for Its #FDAPrecert Program”; http://sco.lt/4hpYzR
Pharma Guy's insight:

I question how Verily got on this list. Talk about revolving doors! Just by coincidence former FDA commissioner Califf joined Verily last May (read “Life After #FDA: Califf May Join Google's Life Sciences Tech Arm Verily”; http://sco.lt/5idYmX). Not only that, “Scientists [are] Skeptical of Google's ‘Verily’ Life Sciences Technology”; http://sco.lt/88okQT

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