Vivos Inc (RDGL)

[Musical Shares]

Yes, it is a device.

The FDA only classifies products as devices or drugs. Not both.

But it is still a drug-device combo according to the FDA rules:

The device is the hydrogel and the drug is the radioisotope.

Combination products are defined in 21 CFR 3.2(e). The term combination product includes:

A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;