The Regulatory Landscape of Orthobiologics - If I'm Confused, You Must Be Too-Session Presentation

Video Transcription

Video Summary

The transcript discusses the regulatory landscape of orthobiologics and the confusion surrounding it. It highlights the different regulations and criteria for various orthobiologic products such as PRP, BMAC, and MFAT. The transcript also mentions the same surgical procedure exception and the guidelines for advertising orthobiologics. It states that PRP is not considered an HCTP and is not regulated by the FDA, while BMAC and MFAT fall under different regulatory categories depending on their manipulation and homologous use. The transcript acknowledges that there are still many unanswered questions and that the regulatory landscape is subject to change. It advises caution in advertising orthobiologics and suggests referencing scientific studies and consensus statements to support treatment claims. The transcript also mentions recent court cases and lawsuits related to the regulation of orthobiologics. Overall, it emphasizes the need for practitioners to stay up to date with regulations and to exercise caution and transparency when discussing and using orthobiologics.

Keywords

regulatory landscape

orthobiologics

confusion

PRP

BMAC

MFAT

FDA

manipulation

transparency