The recently announced FDA pre-cert program is likely to expand the market for innovative new digital health solutions while also providing a boost for traditional medical device companies. However, there are likely to be some important exclusions.
Many startups are focused on developing products designed specifically for healthcare consumers, primarily by way of mobile apps. However, some start-ups are faced with a barrier in the form of the regulatory hurdles put in place by the FDA to eliminate any products not suitable in a clinical grade context. A Quintiles study in 2016 found that while upwards of 165,000 mobile health apps have been created, very few were clinically approved.
In his article for CIO, Paddy Padmanabhan explains “the FDA pre-cert program is likely to expand the market for innovative new digital health solutions while also providing a boost for traditional medical device companies. It may be a while before the pilot program is formalized for open participation by the broader digital health and medical device industry.”
The new program will begin to change this issue, not by sacrificing any of the safety and efficiency regulations, but rather by catching up with the times and allowing for language that accommodates new technologies.
August 28th, By: Paddy Padmanabhan at CIO