IOF Regulatory Warning:
Exosome Products 

The Interventional Orthopedics Foundation (IOF)  is dedicated to helping our members become orthobiologic experts through education and the practical application of regenerative medicine standards. We’re committed to helping you stay up-to-date on all industry developments and regulations to ensure your practice’s success. 

In June 2019 the FDA launched the TRG Rapid Inquiry Program (TRIP) which helps manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to physicians or patients obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. Resources permitting, the FDA will respond within 3 business days to each inquiry that contains sufficient detail for evaluation, for free. 

IOF member Dr. Chris Rogers recently submitted a TRIP request regarding the legality of exosomes and received the response below. The response clarifies that exosomes are biologic drugs and should not be used in the U.S. until they are cleared through the proper regulatory channels. Physicians buying and injecting these products are in violation of FDA regulations. Please exercise caution and do not put your practice or patients at risk by using these products until they are regulatory compliant.

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