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Medical Devices / Submissions and Approvals

Apple, Fitbit Among FDA’s Picks for Device Software Pre-Certification Pilot

Oct. 4, 2017
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The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from startups to giants in the space.

Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Alphabet’s Verily were chosen to provide the agency feedback through the program, launched earlier this year, to reduce the time and cost of market entry for digital health solutions.

CDRH associate director for digital health Bakul Patel told FDAnews the agency purposefully selected emerging companies in digital health as well as legacy tech companies to learn from development perspectives from different sides of the sector.

Patient safety, clinical responsibility, delivering high-quality products and being proactive are some of the principles the FDA considered when deciding on which companies to pick, Patel said. There were a total of 103 applicants.

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