Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs): Risk-Reviewed ACTPs

FDA’s Center for Veterinary Medicine’s (CVM’s) oversight of ACTPs includes, where appropriate, an evaluation of safety and effectiveness with a particular focus on safety and is based on risk (see Cell-Based Products for Animal Use guidance (GFI 218)).  

Below is a list of those ACTPs that, following a risk-based review of product-specific information, FDA has determined that we do not expect submission of an application for approval prior to marketing. For these products, we have determined that we understand the product’s risks for the specified intended use, the risks are appropriately mitigated, and we have concluded we have no additional safety concerns. If FDA becomes aware of new information about risk, it may revisit these decisions. If you believe your ACTP has these types of risks, i.e. that FDA might conclude the risks are well understood and appropriately mitigated, please contact us at AskCVM@fda.hhs.gov.

To increase transparency, FDA, with permission from the developer, intends to publish a summary of the types of data and information it evaluated and its conclusions for products completing FDA risk-review that are for food use or first of their kind on the market.

Product Listing

PrecisePRP Equine, equine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma, VetStem, Inc. (Risk Assessment Summary)

PrecisePRP Canine, canine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma, VetStem, Inc. (Risk Assessment Summary)

StablePlate RX, canine allogeneic lyophilized platelets, BodeVet, Inc., a subsidiary of Cellphire Therapeutics, Inc.