What is it, and what has been done?
In late July the FDA celebrated the one-year anniversary of the Digital Health Innovation Action Plan. This initiative (run by the Center for Devices and Radiological Health) is focused on improving and streamlining the agency’s approach to digital health products in categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. The goals of the plan included increasing the number and expertise of digital health staff at the FDA, launching a pilot program for digital health software precertification (called Pre-Cert), and issuing guidance on digital health.
What has been completed in the first year of the plan?
1) Six guidance were issued last year, including:
o Software as a Medical Device (SAMD): Clinical Evaluation – final
o Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices– final
o Medical Device Accessories – Describing Accessories and Classification Pathways– final
o Deciding When to Submit a 510(k) for a Software Change to an Existing Device– final
o Clinical and Patient Decision Support Software– draft
2) Launch of the Software Pre-Certification Pilot Program to build a conceptual, technical, and regulatory framework allowing companies to pre-certify through the program to streamline pre-market review and reduce patient risk with new medical software. Activities included:
o Selection of 9 companies to participate in the pilot program (from over 100 applicants, see this link for the notice of application)
o Development of a working model for the pilot
o Hosting a public workshop on the program
o Hiring 3 Entrepreneur-in-Residence Fellows to support the development of the program
The official pilot program, called Pre-Cert 1.0, is expected to be available for pilot testing in September 2019. Meanwhile the agency is, as always, looking for feedback on the program (here’s the feedback link). You may follow the program at its website or on Twitter at #FDAPrecert.
Observers expect the Digital Health program to produce more innovations over the next year. For more details on the program, read the full action plan here and visit the Digital Health webpage.
Text Copyright © 2018 Katrina Rogers