Medical Devices

The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]

Durable medical equipment companies need to review the Anti-Kickback Statute, Stark Law, HIPAA, CMS requirements, and other federal and state requirements before marketing their business.

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.