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Medical Devices / Regulatory Affairs

CDRH Plans to Complete Pre-Cert Program Design By Year’s End

Feb. 6, 2018

CDRH intends to complete the design of its digital health software pre-certification program by the end of this year, Associate Director Bakul Patel said during an FDA workshop on developing the Pre-Cert program.

The agency launched a pilot program last year, selecting nine digital health companies — Apple, Tidepool, Phosphorus, Fitbit, Alphabet’s Verily, Johnson & Johnson, Roche, Pear Therapeutics, and Samsung — for their unique development approaches. At the Jan. 30-31 workshop, executives from the companies shared their stories about when FDA staff visited their facilities late last year to begin collaborating on the program. 

How is organizational excellence defined for the purposes of digital health development? “We still do not know, but we are in the process of establishing this standard with the information gathered through the Pre-Cert program,” Patel said.

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