RETURN RECEIPT REQUESTED
August 17, 2004
Mr. Bob Salvin, President
Salvin Dental Specialties, Inc.
3450 Latrobe Drive
Charlotte, NC 28211
Dear Mr. Salvin:
The Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has reviewed your Internet website http://www.salvin.com for the Salvin Sealed Technology Centrifuge and the Salvin Sealed Technology Centrifuge - 220 Volts. Your website claims that these centrifuges separate the platelet rich plasma layer from patients' blood to assist tissue healing and bone mineralization. Copies of the pertinent Internet website pages are attached for your reference.
The Salvin Sealed Technology Centrifuge and the Salvin Sealed Technology Centrifuge - 220 Volts are medical devices within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (Act) because they are instruments or machines intended for use in the cure, mitigation, or treatment of disease. The law requires that manufacturers of medical devices obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that medical devices are safe and effective or substantially equivalent to other devices already legally marketed in the United States.
A review of our databases disclosed that your firm has not obtained premarket approval or clearance for these centrifuges. Because you do not have marketing approval or clearance from FDA, marketing these products is a violation of the law. In legal terms, the products are misbranded under section 502(o) and adulterated under section 501(f)(1)(B) of the Act. Your product is misbranded under the Act because you did not submit a premarket notification under section 510(k) of the Act. Unless you submit a section 510(k) premarket notification, and FDA reviews it and notifies you that your device is substantially equivalent to a legally marketed device, your product is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).
If you have any questions regarding this matter, you may contact Ms. Anna Flynn at (301) 827-6201
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James S. Cohen, J.D.
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Internet website pages from http://www.salvin.com