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Software At The Speed Of Trust: US FDA Launches Pilot To Expedite Digital Health Products

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.

Rubber stamp over white background with the text certified printed on it. concept image for illustration of certification or guarantee certificate.

Calling it a "once in a lifetime opportunity," FDA's top digital health official is encouraging companies to sign up for a pre-certification pilot that could allow them to get health software to market sooner and, in some cases, without filing a pre-market application.

After months of floating the idea to industry, FDA announced July 27 that companies can sign up for a pilot of the Digital Health Software Precertification Program ,or PreCert. The program will rely on FDA certifying and gaining trust in a firm's software-development practices

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