Biologics

Untitled Letter to Dr. PRP America Over Unapproved Device

David McFarland

— 1 min read
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CBER has sent San Diego-based Dr. PRP America an untitled letter over the unapproved marketing of its medical device Dr. PRP Kit for Platelet Rich Plasma (PRP) separation. The letter comes after the Center reviewed the company’s Web site www.drprpamerica.com on 11/2 and found violative product claims, such as: 

  • “Normal baseline concentration levels for blood platelets hovers around 6%, however PRP technology concentrates platelet levels to around 94% with the use of a centrifuge.”
  • “[The] PRP Kit contains tools for concentrating and extracting blood platelets and adjusting blood plasma levels.”
  • The Dr. PRP Kit “aids in the acceleration of our body’s natural healing process to solve the various medical challenges patients face today.”  

CBER said that its review of databases found that the firm has not obtained premarket approval or clearance for the Dr. PRP Kit used with or without the PRP Centrifuge.

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