|Subject:||Labeling/Unapproved New Animal Drug/Adulterated|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||Feb. 22, 2007||Closed:||
Department of Health and Human Services
Public Health Service
2098 Gaither Road
VIA FEDERAL EXPRESS
FEB 22 2007
President & CEO
353 St Nicolas Street, Suite 105
Montreal, Qc (Canada)
Dear Mr. Rambaud:
This letter is in response to the Food and Drug Administration's (FDA's) review of your web site www.seryx.com, and the information you provided to The Office oft Vitro Diagnostic Devices (OIVD) in FDA's Center for Devices and Radiological Health in a telephone conference on May 23, 2006 discussing the Signature Genetics software program. At the May 23, 2006 meeting, FDA suggested that Seryx prepare and send a Pre-Investigational Device Exemption submission as a way to begin a dialog to determine the best way to obtain 510(k) clearance or Premarket Approval for the Signature Genetics software program. Based on our review of your web site and information you provided to us, we have determined that Signature Genetics software is a "device" within the meaning of section. 201(h) of the Act (21 U.S.C. 321 (h)) which is currently being unlawfully marketed.
Seryx's Signature Genetics system contains software used to analyze data and generate a patient-specific report via [redacted] interpretation of a patient's genotype for several drug metabolizing enzymes. This software's rules structure was developed by [redacted ] A patient's genotype test results for these drug metabolizing enzymes are entered into the Signature Genetics program and the software analyzes the laboratory results an other clinical parameters (e.g., drug allergies, concomitant medications) to generate a report, that includes recommendations to the health care provider about whether a patient's, therapy should be adjusted and/or whether there are possible drug drug interactions. information by Seryx at the May 23, 2006 meeting states that the program is designed to "improve drug therapy." Based on our review of your web site, you are currently marketing the Signature Genetics software program. The web site explains, for example, that "information provide in the report is intended to inform the physician if specific adjustments and considerations are indicated for patient based on the patient's drug regimen and genotype results."
Under section 201(h) of the Act. this software 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. The law requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from 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.
Our records do not show that you obtained approval or marketing clearance before you began offering your product for sale. 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/3122.html . The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Because you do not have marketing approval or clearance from the FDA, marketing your product is a violation of the law. In legal terms, your product is adulterated under section 502(o) of the Act, 21 U.S.C. 352(o). Your product is misbranded under the Act because premarket notification under section 510(k) of the Act, 21 U.S.C. 360(section 510(k) premarket notification and FDA reviews it and notifies substantially equivalent to other legally marketed devices for which your product is adulterated under the Act because the law requires, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending 21 CFR 807.81(b).
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.
Your response should be sent to: James L. Woods, Deputy Director, Patient Safety and Product Quality, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road, Rockville, MD 20850. If you have any questions about the contents of this letter, please contact Tara Goldman, at 240-276-0719.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter addresses only the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Steven I. Gutman, M.D., M.F3.A.
Office of In Vitro Diagnostic Devices
Evaluation and Safety
Center for Devices and Radiological Health
Fax: Patrick Rambaud [redacted]
cc: Jeff Gibbs