Illuminating the Risks: FDA Clearance Does Not Fully Shield Health & Wellness Devices from Advertising Scrutiny

The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and monitoring biometrics to managing pain. Depending on the device’s claims and functionality, such devices may also require U.S. Food and Drug Administration (FDA) premarket clearance, often via the so-called 510(k) pathway. To obtain FDA 510(k) clearance, a manufacturer must…
By: Loeb & Loeb LLP