top of page

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and intellectual property considerations. If you are developing a digital health or software product, it may contain software functions that are considered “devices” as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act and are subject to US. Food and Drug Administration (FDA) oversight as devices.

Which Digital Health Products are Subject to FDA Regulations? (

bottom of page