FDA has published its plan for medical device regulatory guidance development in 2015 (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery).
Four items on the ‘A’ list, all of which the agency plans to complete are highly relevant to connected health. These include:
- General wellness products
- Medical device accessories
- Medical device decision support software
- Adaptive design for medical device clinical studies
The first three topics are all about determining the location of the dividing line between regulated and unregulated products, including the middle ground of products that are subject to regulation but will not be under the concept of “enforcement discretion.” Adaptive clinical studies are a key instrument in development of WLSA’s Open Outcomes Based Regulatory alternative to the prevailing method of medical product regulation. (See http://wirelesslifesciences.org/what-we-do/policy-initiatives/oobr/).
