US FDA: Calling All Digital Health Gurus
FDA wants to draw on outside expertise to help it better understand the digital-health industry and to develop its proposed Digital Health Software Precertification Program. The agency is seeking applicants for its Entrepreneur-in-Residence program in the coming months expressly for this purpose.
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Medtech sector representatives say they are optimistic about FDA's plans to accept up to nine companies to participate in a pilot program that could lead to a new pathway for digital health products.
In this video from the inaugural Digital Medtech Conference, in San Francisco, FDA's Bakul Patel discusses the agency's thinking behind a proposed "FDA Precheck" program to expedite the path to market for "software as a medical device" products, and industry players respond.
The agency's device center put out a request to health insurers to make themselves available to participate in FDA pre-submission meetings so that device firms, particularly start-ups, can better understand data expectations for coverage while companies are still designing studies to support FDA approval.