PRP Systems
PRP Systems have guidelines from the FDA to establish guidance for science based regenerative medicine biologic practices. Here are a few questions to ask a regenerative medicine PRP kit supplier.
- Is your product FDA 351 or 361 designated? A cGTP 361 designated company and product cannot make a live cell function claim from a 361 derived tissue.
- What is your medical device classification and what sector of the FDA regulates it? There are two FDA sectors that regenerative companies operate under. CBER is the Center of Biologic Evaluations & Research. The CBER provides expertise in blood, blood products and cellular therapies. This clearance route assumes that the centrifuge output product has a biologic intended purpose, and legally must be called platelet rich plasma(PRP) regardless if from whole blood or bone marrow. identifying a product as PRP does not mean that the biologic only contains concentrated platelets. Centrifuge machines that obtain clearance in the CBER sector start with a “BK” and ascertains an in vivo indication for use. The CBER classification enables a centrifuge manufacturer to claim that use of their product is “on-indication” for application to an orthopedic site. Arthrex Angel and ISTO Biologics Magellan system are classified under CBER.
The second FDA sector in the regenerative companies work under is the CDRH which is the Center for Devices & Radiological Health. The CDRH avenue for a centrifuge product has a in vitro diagnostic purpose and can be called a cellular concentrate, but carries NO clinical application indication. This means that the output product has no planned return to the patient. Meaning there are no orthopedic applications for these devices “on-indication”. Centrifuge model numbers under CDRH start with the letter “K”. CDRH designated centrifuges do not include in vivo indication for use. Emcyte, Apex Biologics, and Terumo BCT’s Harvest system are designated CDRH.
Is the PRP systems self contained? PRP systems should be self contained to reduce handling and contamination
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