2023 Specialty Day All-Access Pass-Update on Regulatory Status: How to Stay out of Jail?

Update on Regulatory Status: How to Stay out of Jail?

Video Transcription

Video Summary

In this video, a speaker discusses the topic of orthobiologics and product development. He mentions that orthobiologics is a growing market, representing nearly 10% of the worldwide orthopedic product sales market. He emphasizes the need for physicians to understand the rules and regulations surrounding orthobiologics, particularly in regards to minimal manipulation and homologous use. The speaker warns that the FDA does not regulate the practice of medicine but focuses on the companies that produce products. He also cautions against false advertising and highlights the increased enforcement by regulatory authorities. The speaker shares his own experience with a Department of Justice subpoena and advises physicians to use legally available products and stay within the boundaries of on-label claims.

Asset Caption

Scott Bruder, M.D., Ph.D.

Keywords

orthobiologics

product development

regulations

FDA

enforcement