Check out new guidance and webinar for details
As I’ve previously mentioned, section 3060 of the 21st Century Cures Act specifically exempts certain types of software functions from FDA regulatory oversight as medical devices. CDRH has issued the final level 1 guidance on these software functions and made level 2 updates to guidance on the individual functions and hosted a webinar on November 4 for interested parties. The biggest changes are in the guidance for mobile medical applications, which now exempts software functions that are intended to:
- Maintain or encourage a healthy lifestyle,
- Serve as Electronic Patient Records, or
- Transferring, storing, converting formats, or displaying data and results.
As long as those functions stop short of being used to treat or diagnose a disease. Innovators should take notice of the broad range of potential health-related tools that are no longer regulated as a device under the new and updated guidance.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers
