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# FDA Announces Pre-Certification Software Pilot Participants
- URL: https://www.fdaweb.com/fda-announces-pre-certification-software-pilot-participants/
- Published: 2017-09-26T12:00:00.000Z
- Updated: 2026-09-14T22:52:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139715

FDA commissioner **Scott Gottlieb** says the agency’s new “Pre-Cert for Software” pilot program is moving forward with the selection of nine company participants in the program — Apple, Fitbit, Google, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool, and Verily. Under the program, CDRH will become a “certifier of firms seeking to go to market with digital health tools,” he said in a [speech to industry](https://www.fda.gov/NewsEvents/Speeches/ucm577416.htm?ref=fdaweb.com) in San Jose, CA 9/26\. It is intended to allow lower risk digital health products to be marketed without FDA premarket review, whereas high-risk products could be marketed with a streamlined premarket review.

Pre-Cert is part of CDRH’s [Digital Health Innovation Action Plan](https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265?ref=fdaweb.com) that details an integrated approach to digital health technology and implementation of the 21st Century Cures Act. “Pre-certification is used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing, and whether it has good, ongoing maintenance of its software products,” Gottlieb said. “Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies.” It will also focus on the product developer rather than just the product, he noted, adding that it could have other applications across our portfolio and may “form part of the framework for a modern legislative approach to laboratory-developed tests.”

CDRH digital health experts will now be working closely with the companies for the rest of the year to “deepen our understanding of their methodologies and how their technologies operate,” Gottlieb said. A public meeting on the proposed framework is being planned for early next year, he said. “We’ve also put out a call for interested experts to come work with the CDRH team for six months to help develop the framework as part of an Entrepreneurs-in-Residence Program, an approach the Center has already used three times in the past. The popularity of this pilot shows that the digital health industry is advancing, with many more traditional and non-traditional healthcare companies developing these applications.”