Myth Six: FDA guidance is flexible and subject to interpretation

The FDA does not regulate the practice of medicine, so what is their place in the discussion of orthobiologics? Their guidance is to the industry, never directly to clinicians. You begin to cross the barrier if you are selling a device–the FDA has clear jurisdiction here.

“The FDA regulates marketing and promotion of drugs, not the practice of medicine. The FDA writes the rules, and they will tell you what they mean. There’s no room for interpretation. If you’re unsure, you can get in front of them for guidance in compliance,” Andrew stated. “If you enter the world of industry, and you don’t get clearance, then the FDA will respond, which could lead to serious charges.”

Play the video to learn when the FDA comes into play.