“The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said it will expand on its digital health pre-certification pilot program by year’s end.”
“Between now and December, testing of the first version of the pilot will continue with more participants, though there will still be a lot of unanswered questions as CDRH is “still figuring out how it should look,” Bakul Patel, digital health director at CDRH, said Thursday at the Association for the Advancement for Medical Instrumentation’s (AAMI) conference in Virginia.”
“Patel said he regrets calling the initial program a pilot because it is better described as a development program co-created with FDA, experts in digital health and other stakeholders.”
“Last December, CDRH selected nine companies — Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily…” Read the full article here.
Source: CDRH to Open Digital Health Pre-Cert Program to More Companies by Year’s End – By Ana Mulero, March 22, 2018. Regulatory Focus.
