The FDA announced that “low-risk general wellness products,” including healthcare wearables and software intended to promote a healthy lifestyle, will no longer be subject to stringent medical device regulation. The agency issued guidance on Jan. 7 to clarify the FDA’s stance on general wellness products, noting that these tools “are not subject to the FD&C Act’s [Federal Food, Drug, and Cosmetic Act’s] regulatory requirements for devices.”
Read the full article: FDA to Ease Healthcare Wearables Oversight //
Source: https://www.techtarget.com/virtualhealthcare/news/366637113/FDA-to-ease-healthcare-wearables-oversight