MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program
The public-private partnership has launched an initiative that aims to help regulators address digital health – in particular the US FDA’s pre-cert pathway for certain medical software.
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The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.
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.