- Seeing the FDA logo displayed on a mobile healthcare application doesn’t necessarily mean the agency regulates the product.
- Unless the device claims to diagnose or treat a known medical condition, FDA approval or clearance is not required. That leaves scores of apps that purport to improve a person’s well-being — calorie counters and fitness devices, for example — outside the agency’s purview.
- Manufacturers of low-risk healthcare apps can still bear the FDA stamp by registering with the agency and listing their products — giving them something extra to trumpet to consumers.
The FDA stamp signals to people a product’s safety and effectiveness have been proven, but that’s not always the case, according to Wired, which looked at scads of health and wellness gadgets at last week’s Consumer Electronics Show in Las Vegas. While high-risk devices, such as pacemakers and spinal implants, require a full regulatory review and approval, others are cleared based on their similarity to previously approved devices and others are exempt and must only be registered and listed.
Included in the “listed” group is Joylux’s vSculpt, “a $345 device that claims to be a ‘vaginal rejuvenator’ and pelvic floor strengthener,” that uses red and infrared LEDs to increase blood flow, according to Wired. Because rejuvenation isn’t an actual medical claim, the FDA doesn’t regulate that. Not so with the pelvic floor claim. It’s all in how you word your marketing message.
In a January 2015 draft guidance, the FDA said it doesn’t plan to examine low-risk general wellness products to determine if they are devices within the meaning of the Food Drug & Cosmetic Act or if they comply with premarket and postmarket regulatory requirements. To fit the category, products — including software apps — must be intended only for general wellness use and pose a very low safety risk.