Inspections, Compliance, Enforcement, and Criminal Investigations
Talcon Acrylics, Incorporated 11-May-06
Department of Health and Human Services
Public Health Service
May 11, 2006
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-28
Sherman L. Watson, President
Talon Acrylics, Incorporated
850 Northeast 102nd Avenue
Portland, OR 97220
Dear Mr. Watson:
We are writing to you because on January 12, 13, 17, and 20, 2006, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving products known as the Revere® and Talon® Thermoplastic Acrylic Elastomers which are made and marketed by your firm.
Under a United States law, the Federal Food, Drug and Cosmetic Act, each of these products is considered to be 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, section 201(h) of the Act, 21 U.S.C. 321(h). The law 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 newly introduced devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
Our records do not show that you obtained marketing approval or clearance before you began offering your products for sale. We understand from your prior interactions with the Agency that you maintain that your devices are covered by 510(k) clearance numbers K900799 and K910795, which were issued to Comfort Acrylics. In our inspection, however, you did not provide documentation establishing that ownership of these 510(k) clearances has been transferred to you personally or to Talon Acrylics. The documentation [redacted] makes no mention at all of these 510(k)s. It is your firm's responsibility to establish compliance with the requirements for premarket clearance or approval, either by obtaining documentation establishing the transfer of ownership of the existing 510(k)s, or by making appropriate premarket submissions.
The kind of information you need to submit in order to obtain approval or clearance is described on FDA's device web site at http://www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your product may be legally marketed. If you have any questions pertaining to the submission of 510(k)s for your specific products, please contact Dr. Susan Runner at 301-827-5283 ext. 117.
Because you do not have marketing approval or clearance from the FDA, marketing your products is a violation of the law. In legal terms, these products are adulterated under section 501(f)(1)(B), 21 U.S.C. 351(f)(1)(B), and misbranded under section 502(o) of the Act, 21 U.S.C. 352(o). Your products are misbranded under the Act because you did not submit section 510(k) premarket notifications, which are required by 21 U.S.C 360(k), that show your devices are substantially equivalent to other devices that are legally marketed. Until you submit section 510(k) premarket notifications and FDA reviews them and notifies you that you may market your devices, your products are also adulterated under the Act because the law requires, and you do not have, approved premarket approval applications that show your devices are safe and effective. 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.
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.
It is necessary to take action on this matter now. 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 to Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the contents of this letter please contact Lisa Althar at (425) 483-4940.
Finally, 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 review for your device and does not necessarily address other obligations you have under the law.
Charles M. Breen