'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means
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.
You may also be interested in...
Software Pre-Certification Program Highlights Needs For Legislative Change, FDA Says
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.
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.
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.