Early this month the FDA quietly announced a new initiative centered on improving medical device regulation and innovation.
The announcement was made in the form of a blog post on June 15th written by Scott Gottlieb, M.D., Commissioner of the FDA. The new Digital Health Innovation Plan that is proposed involves creating a third party organization to expedite medical device endorsement:
While the pilot program is still being developed, we are considering whether and how, under current authorities, we can create a third party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.
According to the post, last year there were 165,000 health apps available for download on smartphone app stores. Access to health technology has the potential to change the way populations think about their health. But the current process for device and technology approval can be tedious. The new initiative will implement a streamlined review process for both low and high risk products as part of a comprehensive plan to tackle barriers that exist for health technology implementation.
The new initiative also emphasizes the potential of data. Patient health records, payer claims, registries and so on provide insight into population and provider behaviors that can determine the best course of action for treatment, product innovation and a host of other uses.