2018 Orthobiologics Surgical Skills Online-3 - Regulations by Ken Vaslav, MD

Video Transcription

Video Summary

The speaker in the video discusses the regulations and guidelines surrounding the use of orthobiologics and regenerative medicine in the United States. The FDA has recognized the need to regulate these products due to the increase in advertising and patient recruitment for untested treatments. The FDA has put out a regulatory considerations document, which defines what is considered a human cellular and tissue-based product (HCTP) and what is not included. The document also outlines the criteria that HCTPs must meet to be exempt from regulation, such as minimal manipulation and homologous use. There is also a same surgical exception, which exempts products that are removed from and implanted back into the same individual during the same surgery. The FDA will regulate all products that do not meet the exemption criteria. The speaker explains the definitions of minimal manipulation and homologous use, as well as the steps practitioners must take to determine whether their product falls under the exemption criteria or requires regulation. In summary, the speaker emphasizes that we are entering a new phase of tissue and cellular biologic repair, and while regulations are necessary to ensure safety, they can also hinder product development.

Keywords

orthobiologics

regenerative medicine

FDA regulations

human cellular and tissue-based product

exemption criteria