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 FDA categorizes biologic products into two groups: 361 products, which are considered safe and minimally manipulated, and 351 products, which require an Investigational New Drug (IND) application. Regulations, especially regarding terms like "minimally manipulated" and "homologous use," remain vague and evolving. Despite enforcement challenges, the FDA has ended its enforcement discretion as of May 2021, meaning clinics not following rules risk legal action. Many products, especially certain amniotic and adipose tissues, often operate outside regulations. Patients should be cautioned about risks, as some treatments lack efficacy and safety, emphasizing the need for informed consent and adherence to FDA guidelines.

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Dr. Stephen Weber

Keywords

FDA biologic product categories

361 products

351 products

minimally manipulated

FDA enforcement discretion