FDA Pitches Novel Pathway For Software
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.
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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.
Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.
Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.