The American FDA wields some power over approving medical devices. It’s certainly less stringent than their regulatory power over drugs, but sometimes there’s a subtle distinction between what constitutes a drug or device. Here’s some insight into how regulators decide, via a Reuters story about the Decapinol oral rinse:
The oral rinse is being regulated as a medical device and not as a drug because its primary mode of action is to create a physical barrier, rather than to act chemically. The product contains a surfactant that acts as a physical barrier, making it harder for bacteria to stick to tooth surfaces. FDA also has approved a number of other anti-gingivitis oral rinses, but since these products act chemically to kill bacteria that live in the mouth, they are regulated as antimicrobial drugs rather than as devices.
More about the rinse at Sinclair Pharmaceuticals…