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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FaceMaster of Beverly Hills, Inc. 27-Aug-03

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

2098 Gaither Road
Rockville, Maryland 20850


August 27, 2003

WARNING LETTER

FEDERAL EXPRESS

Mr. Jim England
General Manager
FaceMaster of Beverly Hills, Inc.
23679 Calabasas Road, PMB 665
Calabasas, California 91302

Dear Mr. England:

The Food and Drug Administration (FDA) notified your firm in a letter dated February 19, 2002, of the need for your firm to submit a marketing application for the FaceMaster of Beverly Hills (FaceMaster) before marketing this product in the United States because it is intended to affect the structure or any function of the body and is, therefore, a “device” under Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h)(3). The law requires that manufacturers of devices obtain marketing clearance for their products from FDA before they introduce them into interstate commerce. This helps to protect the public health by ensuring that new devices are shown to be either safe and effective or substantially equivalent to other devices already legally marketed in this country.

On March 22, 2002, you responded that your firm would file a 510(k) premarket notification submission with the FDA. On May 23, 2002, the FDA sent you another letter stating that no premarket notification submission had been received from your firm. In response, your firm filed a premarket notification submission with the FDA, which was assigned 510(k) number K022830. On October 4, 2002, the Office of Device Evaluation issued a 30-Day Cannot Respond letter, identifying major deficiencies in your submission that prevented FDA from determining whether or not your device was substantially equivalent to legally marketed class I or class II devices. Because your firm did not provide information to remedy those deficiencies within 30 days, your submission is considered to have been withdrawn, under Title 21 Code of Federal Regulations (CFR),Section 807.87(l).

A review of the website www.facemaster.com indicates that you are continuing to solicit Internet orders for the FaceMaster. Because your products do not have marketing clearance or approval from FDA, they are in violation of the law. Under section 513(f)(1) of the Act, until you receive a determination from the FDA that the FaceMaster is substantially equivalent to a legally marketed class I or class II device, or until the FaceMaster is reclassified into class I or class II, your product is a class III device. The Act requires manufacturers of class III devices to obtain premarket approval based on information that shows your devices are safe and effective. As described above, your 510(k) premarket notification submission contained major deficiencies that prevented FDA from determining whether the FaceMaster is substantially equivalent to other legally marketed class I or class II devices. Because your device thus remains in class III and you have not obtained the premarket approval required by section 515(a) of the Act, in legal terms, your products are adulterated under Section 501 (f)(1)(B) of the Act.

You should know that this serious violation of the law might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or seeking civil money penalties. Also, other Federal agencies are informed about the warning letters we issue, such as his one, so that they may consider this information when awarding government contracts.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket clearance for your devices and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA’s requirements for manufacturers of devices by contacting our Division of Small Manufacturers Assistance at 1-(800)638-2041 or through the Internet at www.fda.gov.

Please notify this office in writing, within 15 working days, of the steps you are taking to correct the noted violation. We also ask that you explain how you plan to prevent this from happening again. Please address your response to:

Christy Foreman, Chief
Orthopedic, Physical Medicine & Anesthesiology Devices Branch
Division of Enforcement III, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850

If you have any questions, please contact Ms. Erin Keith at (301) 594-4659 extension 117.

Sincerely yours,
/s/

Larry D. Spears for Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health