Industry Experts Give FDA’s Pre-Cert Program Thumbs-Up
A panel of industry experts gave the US FDA’s Digital Software Precertification Program the thumbs-up during a MedCon session.
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In a report published September 26, the FDA released the findings from its software pre-certification program which include the need for a new regulatory authority to supplement current regulations for medical devices.
The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.
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.