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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hardy Diagnostic 08-Jan-07

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

Public Health Service
Food and Drug Administration

 

2098 Gaither Road
Rockville MD 20850


 

WARNING LETTER

 

VIA FEDERAL EXPRESS {AND FACSIMILIE}

JAN 8 2007

Jay Hardy
President
Hardy Diagnostics
1430 West McCoy LN
Santa Maria, CA 93455

Dear Mr. Hardy:

The Food and Drug Administration (FDA) learned through your recent voluntary recall, Z-0078-2007, that your firm is marketing the HardyCHROM 0157 in the United States (U.S.) 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 HardyCHROM 0157 is a device because it 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, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt 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 new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, HardyCHROM 0157 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). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 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. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3133.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter . We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to James L. Woods and the address on the letterhead.

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 review for your device and does not necessarily address other obligations you have under the law.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health