Inspections, Compliance, Enforcement, and Criminal Investigations
Canam Medsource Ltd 16-Apr-04
Department of Health and Human Services
Public Health Service
Center for Devices and
APR 16 2004
VIA FEDERAL EXPRESS
Paul B. Morrow
Canam Medsource Ltd.
24 West Hatfield St.
Massena, New York 13662
Dear Mr. Morrow:
We are writing you because the Food and Drug Administration (FDA) has obtained information from your Internet web site, www.skinstitch.com, that revealed a serious regulatory problem involving the product known as Skinstitch Topical Skin Adhesive, which is manufactured and marketed by your firm.
Under a United States federal law, known as the Federal Food, Drug and Cosmetic Act (the Act), this product is a medical device because it is intended for use to diagnose or treat a medical condition. The law generally requires that manufacturers of medical devices 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 newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
Our records show that you listed Skinstitch as a liquid bandage, a Class I device which according to 21 CFR 880.5090 does not require a premarket notification submission (510(k)) if only used as a skin protectant. However, statements on your web site indicate that Skinstitch skin adhesive is intended for use to close broken skin. For example:
"Skinstitch is an amazing, cost effective, skin adhesive used in the painless repair of skin lacerations....."
"Now that the benefits of liquid adhesives for cuts have become popular, Skinstitch adds to these benefits...."
"[Skinstitch is] being used throughout our radiology departments as an effective means of primary closure for radiological procedures."
Statements such as these indicate that Skinstitch is intended for use as a surgical adhesive, to close broken skin, a use which requires FDA premarket review. In fact, the trade name of your product -- Skinstitch --itself implies that the product will "stitch" skin together, a use which goes beyond an intended use as a topical skin protectant, which is the only use exempt from premarket review. The name of your product also indicates that it is an adhesive, further evidence that it is intended for use to adhere skin together. However, our records do not show that you obtained marketing approval or clearance before you began offering your product for sale.
Because you do not have marketing clearance from the FDA, marketing your product is a violation of the law. In legal terms, the product is misbranded under section 502(o) and adulterated under section 501(f)(1)(B) of the Act. Your product is misbranded under the Act because you did not submit a premarket notification under section 510(k) of the Act. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that your device is substantially equivalent to other legally marketed devices, your product is also adulterated under the Act because the law requires an approved premarket approval application that shows your device is safe and effective, which you do not have. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).
You should know that this serious violation of the law may 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 assessing 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 let this office know 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 to Wayne Q. Miller, Consumer Safety Officer, General Surgery Devices Branch, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road, HFZ-323, Rockville, Maryland 20850.
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 approval or clearance for your device 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 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.
If you have more specific questions about how FDA marketing requirements affect your particular device, or about the content of this letter please feel free to contact Wayne Q. Miller at 1-301-594-4618, EXT. 122.
Timothy A. Ulatowski
Office of Compliance
Center for Devices