Inspections, Compliance, Enforcement, and Criminal Investigations
Generic Medical Devices, Inc. 4/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
April 28, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-09
Robert P. Cummins, Chief Executive Officer
Generic Medical Devices, Inc.
5727 Baker Way NW, Suite 201
Gig Harbor, Washington 98332
Dear Mr. Cummins:
The United States Food and Drug Administration (FDA) has determined that your firm manufactures the GMD Universal Urinary Incontinence Sling. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product 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 are intended to affect the structure or function of the body.
The Universal Urinary Incontinence Sling Model 1011 has been determined to be 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 device is 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 device 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. 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.
This charge is supported by the failure to submit a premarket notification submission to the Food and Drug Administration for the Universal Urinary Incontinence Sling, Model 1011 that your firm offered as a replacement for the Universal Urinary Incontinence Sling, Model 1010 in the “GMD Product Representatives” email dated May 12, 2010. Failure to submit a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i). The changes to Model 1011 were based upon significant design or manufacturing changes made to the Model 1010 device. These changes included:
(1) Changing the manufacturing process of (b)(4);
(2) (b)(4) of the sheath from (b)(4) to(b)(4);
(3) Moving (b)(4) on the sleeve; and
(4) (b)(4) on the sleeve to provide less resistance in situ.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Additionally, requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Mr. Peter Chow, Compliance Officer, Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, WA 98021. Refer to Warning Letter SEA 11-09 when replying. If you have any questions about the content of this letter please contact: Mr. Peter Chow, Compliance Officer at 425-483-4766.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Charles M. Breen