FDA Guidance on Studying and Marketing Medical Devices – Part Two
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps three and four.
The FDA Transcranial Magnetic Stimulation Approval Process
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 [...]
Compliance Issues for Durable Medical Equipment Companies
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 My Product to be a Medical Device?
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.
