In mid-2017, the U.S. Food and Drug Administration (FDA) published the Digital Health Innovation Action Plan. At the same time FDA’s current Commissioner, Scott Gottleib, MD, launched the Software Precertification Pilot Program, simply called Pre-Certification or Pre-Cert program.
This program, developed under FDA’s Center for Center for Devices and Radiological Health (CDRH), recognizes the uniqueness’s of digital health technologies, in their promise to improve the health of the public and the frequent iterative process of product improvements. A key aim of Pre-Cert is to assure delivery and access to high-quality, safe and effective digital health products in a timelier and less burdensome process.
To create Pre-Cert, FDA is conducting a pilot with nine companies (link: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577480.htm). The pilot, considered a first step in this process, is designed to collaborate with the full ecosystem of stakeholders to achieve success. Phase 1 included site visits to the pilot organizations. Phase 2 was a public workshop, Fostering Digital Health Innovation: Developing the Software Precertification Program, held January 30-31, 2018.
This public workshop delved into the program’s progress and sought input from the nine pilot players on their visions for the Pre-Cert program. To be clear, these nine entities were not chosen by FDA as the first to obtain Pre-Cert status, rather they’re helping to design the process FDA will put in place. Complete archives of the workshop are available (link: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm587581.htm?utm_content=buffere281c&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer).
Anand Iyer, PhD, MBA, WellDoc’s Chief Strategy Officer, presented at and attended this workshop. He has been involved long term in the thinking behind this innovative FDA program. He shares his top line take aways here:
Follow the evolution of this novel program on Twitter at: #FDAPreCert
Check out the top line take aways from this public workshop from digital health clinician and researcher, Malinda Peeples, RN, MS, CDE, WellDoc’s VP, Clinical Services, Programs and Research.
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