FDA WARNING_LETTER - Generic Medical Devices, Inc.

The FDA issued a Warning Letter to Mr. Cummins regarding the GMD Universal Urinary Incontinence Sling, Model 1011, which is classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The device is deemed adulterated under section 501(f)(1)(B) because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE).

Furthermore, the device is misbranded under section 502(o) as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k). This violation specifically pertains to the Model 1011, offered as a replacement for Model 1010, without submitting a premarket notification for significant design or manufacturing changes. These changes include altering the manufacturing process of (b)(4), changing the (b)(4) of the sheath from (b)(4) to (b)(4), moving (b)(4) on the sleeve, and (b)(4) on the sleeve for less in situ resistance.

The FDA requires prompt corrective action to prevent regulatory actions such as seizure, injunction, civil money penalties, and denial of Certificates to Foreign Governments. The firm must respond in writing within fifteen working days, detailing corrective steps, prevention plans, and a timetable for implementation.