Today, digital health seed accelerator, Rock Health released their newest report, FDA 101: A Digital Guide to the FDA for Digital Health Entrepreneurs to serve as an introduction to navigating FDA regulation around medical devices and mobile medical apps.
The report was produced by Rock Health’s Chief Strategy Officer, Malay Gandhi and Entrepreneur in Residence, Deborah Pascoe, PhD with help from senior analyst, Holly May from Health Advances.
The report covers the following:
- scope of regulatory oversight
- regulatory path
- classes that define a mobile medical app
- 510(k) process
- PMA process
- Pro-tips
The report also features advice from startups that have been received FDA clearance such as AgaMatrix, WellDoc, and AliveCor.
For more information, please see the full report below:
Rock Health is the first seed accelerator for digital health startups. We’ve created an ecosystem of passionate individuals–from investors to startup founders to doctors–who work together tirelessly to make meaningful change in healthcare through scalable, innovative technology.
