Earlier this year, MDIC hosted a webinar with experts from FDA, a consumer electronics and fitness firm, a medical device manufacturer as well as patient advocates to discuss the existing regulatory framework for digital health, key considerations for patients and healthcare providers, and implications for the future of digital health innovation. The Digital Health working group has identified 5 initial workstreams to complement FDA’s efforts to develop an innovative regulatory pathway for software that is tailored to its unique and iterative nature, including leveraging the learnings from the FDA pre-cert pilot program.
The initial workstreams are:
- Change Control
- Excellence Appraisal
- Review Determination
- Streamlined Premarket Review
- Evidence Generation, including Real-World Data (RWD) Collection and use of Real-World Evidence (RWE) such as Patient Generated Data and Computer Modeling & Simulation
To learn more about opportunities to collaborate, please contact Jithesh Veetil (jveetil@mdic.org).
