Source: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm351274.htm
Timestamp: 2019-04-25 07:49:30+00:00

Document:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed a tri-fold patient brochure entitled, “RegenPlasma™ Unleashed!” and a professional brochure entitled, “RegenPlasma™ Unleash-the Power of PRP in Your Practice!” These brochures provide evidence that RegenLab America Inc. (RegenLab) and Eclipse Aesthetics, LLC (Eclipse) are marketing RegenKit®THT in the United States (U.S.) for new intended uses without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act, the RegenKit®-THT is a device because it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body of man or other animals (21 U.S.C. §321(h)).
Additionally, your marketing materials contain “before” and “after” pictures of patients’ skin that supposedly have benefited from the use of the RegenKit®-THT.
The claims concerning RegenKit®-THTin your brochures are evidence of major changes or modifications to the cleared intended use for this device that could significantly affect its safety and/or effectiveness. Specifically, the statements in your brochures suggest that the output of the RegenKit®-THT is safe and effective for clinical indications in the area of cosmetic surgery. However, the clearance letter for BK090048specifically states that the device is for use only in the “safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements” (emphasis added).
For the above reasons, your RegenKit®-THT device is 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) for the new intended uses of this device.
Your device also is misbranded under section 502(o) of the Act, 21 U.S.C. §352(o) because a notice or other information with respect to the new intended uses for the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. §360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. §360(k), is deemed satisfied when a PMA is pending before the agency (See 21 CFR §807.81(b)). Your brochures’ claims concerning the use of RegenKit®-THT in the area of cosmetic surgery are evidence of intended uses that are not consistent with those cleared in your 510(k) notifications, and the cosmetic surgery claims represent a major change or modification in the intended use that requires the submission of a PMA or a 510(k).
This letter is not intended to be an all-inclusive list of deficiencies associated with your device. It is your responsibility to ensure that you are in compliance with each requirement of the Act and Federal regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice to you. These actions may include, but are not limited to, seizure, injunction, and/or civil penalties.
We request that you immediately cease marketing the RegenKit®-THT for unapproved uses. Please submit a written response within ten (10) business days of receipt of this letter, outlining the specific steps you have taken to correct the violations. Your response should further include a comprehensive plan detailing all steps being taken to address the misleading information currently in the marketplace.
Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to BK090048. We remind you that only written communications are considered official responses.
cc: Tom O’Brien, CEO, Eclipse Aesthetics, LLC.

References: §321
 §351
 §360
 §360
 §352
 §360
 §360
 §807