Inspections, Compliance, Enforcement, and Criminal Investigations
Neoterik Health Technologies 14-Jan-04
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
RETURN RECEIPT REQUESTED
JAN 14, 2004
Neoterik Health Technologies
401 S. Main Street
Woodsboro, Maryland 21798
The Food and Drug Administration (FDA) has obtained information from your Internet web site, http://www.sarssafeandsecure.com>, that reveals a serious regulatory problem involving the MK-32 Safety Mask and the Respirator CF60, which are commercially distributed by your firm.
Your web site recommends or suggests use of these products for protection against Severe Acute Respiratory Syndrome (SARS). The web site states that "SARS prevention through leading edge, health-related respiratory protection products is our business. For over 20 years, Neoterik Health Technologies has manufactured a respected line of respirators and masks to help prevent the transmission of airborne diseases including SARS and TB." The site states that the MK-32 Safety Mask "offers just the right health-related protection against SARS ...." The name of your website, "sarsafeandsecure.com" also suggests use of your products for SARS protection. Consequently, the MK-32 Safety Mask and the Respirator CF60 are intended for use in the cure, mitigation, treatment, or prevention of disease within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.321(h), and are medical devices that are subject to the Act's requirements for premarket approval or clearance by FDA.
Our records do not show that approval or clearance has been obtained for the MK-32 Safety Mask or the Respirator CF60 to prevent SARS transmission or for any other SARS-related indication. Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)), in that they are class III devices under section 513(f) (21 U.S.C.360c(f)) and you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a)(21 U.S.C.360e(a)) or an approved application for investigational device exemption under section 520(g) (21 U.S.C.360j(g)). The products are also misbranded under section 502(o)(21 U.S.C.352(o)), because a notice or other information respecting them was not provided to the FDA as required by section 510(k) (21 U.S.C.360(k)). For a product requiring premarket approval (as opposed to clearance), the notification required by section 510(k) is deemed to be satisfied when a PMA is pending before the agency 21 CFR 807.81(b).
This serious violation of the law may result in the FDA taking regulatory action without further notice to you. Such action can include, but is not limited to, seizing your product inventory, obtaining a court injunction against further marketing your products, or seeking civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
Please respond in writing, within 15 days of receiving this letter, by explaining the specific steps you have taken to correct this violation and to assure that similar violations will not occur. If you need additional time, please explain the reason for the delay and advise us-when you expect to respond. Also, we request that you provide us with the name and address of, and the name of a contact person for the manufacturers of the Efficient Affordable MK-32 Safety Mask and the Battery Powered Respirator CF60.
Please address your response to Ms. Betty Collins, Director, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road (HFZ-320), Rockville, Maryland 20850. If you have any questions concerning the contents of this letter, you may contact Carolyn Niebauer, Chief, General Hospital Devices Branch, or Diane Goldsberry, Technical Information Specialist, by phone at (301)594-4618 or by facsimile at (301)594-4638.
You should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance or approval for your devices and does not necessarily address other obligations you have under the Act. You may obtain general information about FDA requirements for medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or through the Internet at <http://www.fda.gov>.
Finally, in addition to the Act, you may be subject to the Federal Trade Commission Act, which is administered by the Federal Trade Commission (FTC). A copy of this letter is being forwarded to the FTC.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and