The FDA is taking a new approach to the regulation of digital medicine solutions.
“Digital tools are rapidly evolving, and to keep pace with its promising innovation, the FDA must modernise its approach to regulation,” FDA Commissioner Scott Gottlieb said in a statement at the beginning of the year.
The regulatory framework for the Software Precertification (Pre-Cert) Pilot Program has now been published, with nine companies that have been involved in drafting it, including Roche, Apple and Samsung. But what does this mean for the industry?
Pre-Cert aims to supplement existing FDA approval pathways, as recently explored in the HIMSS Insights Global Innovators eBook, which was launched last week at HIMSS19.
The FDA now plans to launch a pilot project to test the Pre-Cert model on new submissions of software from these nine companies that have provided input.
The full article can be accessed here, in the latest issue of HIMSS Insights.
HIMSS is the parent company of MobiHealthNews.