|Company:||Venosan North America|
|Subject:||Medical Device Lacks Premarket approval/Misbranded|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||Nov. 21, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Center for Devices and
Nov 21 2007
VIA FEDERAL EXPRESS
Mr. Robert C. Spalding
Venosan North America
P.O. Box 1067
Asheboro, North Carolina 27204
Dear Mr. Spalding:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Silverline and the Silverline DB medical stockings 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 Silverline and the Silverline DB medical stockings are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any 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 products for sale, which is a violation of the law. Specifically, the Silverline and the Silverline DB medical stockings are 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 devices are 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 devices into commercial distribution, 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. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices 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.
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: Valerie Flournoy, Chief, General Hospital Devices Branch, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd HFZ-333; Rockville, MD 20850-3229. You may contact Ms. Flournoy by telephone at (240) 276-0115 or by facsimile at (240) 276-0114.
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 devices and does not necessarily address other obligations you have under the law.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and