FDA Calls Out Unproven Claims of Unapproved Blood Device

Regulatory NewsRegulatory News
| 28 November 2016 | By Zachary Brennan 

Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels.

Mary Malarkey, director of the Office of Compliance and Biologics Quality at FDA’s Center for Biologics Evaluation and Research, wrote in the letter that a review of FDA’s databases found the company has not obtained approval or clearance for its Dr. PRP Kit used with or without the PRP Centrifuge.

According to the company’s website, the PRP Kit costs $85 and the centrifuge costs $2,199.

FDA says the website makes a number of claims that have not been reviewed by FDA and indicates the devices may be used for a variety of purposes, including the treatment of musculoskeletal injuries and tissue regeneration and rejuvenation.

“The Dr. PRP Kit whether sold with or without the PRP Centrifuge appears to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g),” the letter says. “Additionally, the same device appears to be misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because notice or other information respecting the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. 360(k).”

Dr. PRP America's Marcy Rogers told Focus via email that her company does not manufacture these kits. "We purchased them initially from the manufacturer, Dr. PRP RMedica, based in Seoul who was selling them as a blood tube which in fact they are. They indicated in their promotional materials they were FDA approved as a blood tube. Their company in the US, Dr. PRP USA, is marketing these kits just as we did. We changed suppliers 12 months or longer ago to another vendor in Seoul who also has a blood tool kit and a centrifuge. All of the materials on our website came from the manufacturer...I am working with the FDA to resolve any issues and called their consumer safety officer [on Monday] upon receipt of the letter."


Editor's note: This article was updated on Tuesday, 11/29, with Rogers' comments on the letter.


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