CDRH releases draft guidance clarifying its intention not to evaluate “low risk products that promote a healthy lifestyle (general wellness products)” as medical devices.
CDRH does not intend to examine general wellness products like fitness trackers to see if they qualify as medical devices under the Food, Drug, and Cosmetic Act unless they make reference to diseases or conditions. This policy does not extend to devices that present inherent risk, including devices that raise novel questions of usability or biocompatibility. In order to help manufacturers determine whether their device qualifies as a general wellness product, the guidance includes a decision algorithm that asks yes-or-no questions to evaluate the device’s health claims and level of risk.
With FTC’s recent publication of its Staff Report on the Internet of Things and its enforcement action against a computer game manufacturer for making unsubstantiated (and potentially misbranding) health claims, it seems that the two regulators have started off 2015 with strong statements on who will regulate which aspects of the evolving digital health market.