05 Aug PRP and the FDA
“Platelet rich plasma (PRP) and fibrin matrix (PRFM), or autologous ( same donor same recipient) platelet derived growth factors, are proposed as an adjunct to standard treatment for a number of indications including wound care for the treatment of diabetic ulcers and venous stasis ulcers, bone augmentation and fusion, tendonitis, and plantar fasciitis.
Administration of PRP is a procedure and is, therefore, not subject to regulation by the Food and Drug Administration (FDA). However, the devices used to prepare PRP are regulated by the FDA premarket approval process. Several centrifuge devices have been approved by the FDA for preparation of PRP.” (1)
In other words since PRP is an autologus blood product and “not a drug” it is considered a “procedure” and the method of use i.e. spraying, injecting etc. is not regulated by the FDA only the preparation equipment is and requires 510 K approval.
(1)PLATELET RICH PLASMA/PLATELET RICH FIBRIN MATRIX
Effective Date: July 18, 2008 Review Dates: 6/08, 6/09
Date Of Origin: June 2008
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