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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 26 September 2017 | By Zachary Brennan
US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications.
FDA launched the pre-cert pilot in July as part of the agency’s Digital Health Innovation Action Plan.
The pilot participants, representing a range of companies and technology in the digital health sector, include small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers. Participants selected are:
As part of the pilot, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including the collection of post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system.
In addition to building on his comments on relief efforts for Puerto Rico, where he said FDA has a number of personnel that are coordinating with the Department of Homeland Security, Gottlieb discussed the ways in which the use of real-world evidence is going "viral" at FDA, not just on the device side but also on the pharmaceutical and biotech ends.
In the Q&A portion of his talk, Gottlieb said FDA is seeking to advance the regulation of lab-developed tests through legislation, rather than guidance (the release of which the agency pushed back recently) as "the level of complexity and risk in some of these tests is high" and the issues around reimbursement "are acute. This is a mature industry."
On the topic of opioids, Gottlieb floated the idea of creating a new "pain center," which might be similar to the newly created Oncology Center of Excellence, though he said the idea is still in its early stages.
Tags: Google, Verily, Johnson & Johnson, digital health, medical software