Hype, Promise, and Reality Orthopedic Use of Biologics (2021 Annual Meeting)-Hype, Promise, and Reality: Orthopedic Use of Biologics in 2021'-Weber

Hype, Promise, and Reality: Orthopedic Use of Biologics in 2021'-Weber

Video Transcription

Video Summary

The video discusses the complex regulations surrounding biologics and the FDA's categorization of them into 361 and 351 products. The speaker highlights the vagueness and confusion surrounding terms like "minimally manipulated" and "homologous use." They emphasize the strict rules and lack of cell yield for 361 products. The video warns about the consequences of not adhering to regulations, including receiving cease and desist letters and prosecution from the DOJ. The importance of regulation is emphasized through examples of unsafe practices and negative outcomes. The speaker advises caution and informed consent for patients seeking alternative treatments. The video concludes by mentioning available resources for information and the need to be aware of and adhere to the regulations. No credits mentioned.

Asset Caption

Dr. Stephen Weber

Keywords

biologics

FDA regulations

361 products

minimally manipulated

homologous use