As a single source manufacturer, Ranfac handles everything from raw material to ﬁnal packaging in one location. We’re proud to boast that our products have been 100% manufactured in the U.S. since 1888. We enjoy our wonderful partnerships in the healthcare and medical device industries and are happy to celebrate 2018 and its accomplishments, even a couple of months into the year. It’s never too late to get excited about innovation! We wanted to take an opportunity to look back at some of the wins of 2018 and share our plans for 2019 in the areas of operational improvements, regulatory and quality developments, and sales and marketing achievements.
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.