FDA to expand digital health pre-cert program by end of 2018: 3 things to know

The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.

Here are three things to know about the announcement, which Mr. Patel made during the Association for the Advancement for Medical Instrumentation's conference in Virginia.

1. The FDA launched its Pre-Cert for Software Pilot Program, part of the FDA's Digital Health Innovation Action Plan, in July 2017. The pilot aims to streamline approval for digital health technologies by reviewing developers, rather than individual products. These pre-certified developers would be able launch products without review, so long as the developers collect post-market data to confirm product safety to the FDA.

2. In September 2017, the FDA released the names of the first nine digital health companies to participate in the pilot program, which included tech giants like Apple and Fitbit. The nine companies — which develop products related to software, sensors, technology and connectivity — committed to providing routine feedback during FDA officials' onsite visits.

3. At the AAMI conference, Mr. Patel said the agency will select additional companies to participate in the initial pilot program through the end of 2018. He added he regrets calling the initial program a pilot, specifying the pre-cert program is a development program co-created with the FDA and digital health experts, among other stakeholders.

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