Inspections, Compliance, Enforcement, and Criminal Investigations
Medline Industries Inc., 3/12/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20093
Mar 12 2010
VIA FEDERAL EXPRESS
Lara N. Simmons
Corporate Vice President
Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060
RE SILVERtouch™ textiles with SilverClear® technology
Dear Ms. Simmons,
The Food and Drug Administration (FDA) has learned that your firm is marketing the SILVERtouch™ antimicrobial line of healthcare textiles with SilverClear® technology in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food Drug and Cosmetic Act the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed internet websites for SILVERtouch™ textiles with the antimicrobial SilverClear®. The product is a device within the meaning of Section 201(h) of the Act.
The device is 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. 360c(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) of 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 sections 510(k) of the Act, 21 U.S.C. 360(k).
For example in your website (http://www.medline.com/textiles/linens/sheets/) you state that Silvertouch "utlizes a unique, highly effective solution called SilverClear® which combines the power of silver ions with surface-active antimicrobial chemistry, delivering a fast kill rate across a broad spectrum of microbes (data on file, available upon request). Tested to withstand commercial laundering for the life of the product and remain effective, wash after wash."
The Office of Compliance requests that Medline Industries immediately cease the dissemination of promotional materials for SILVERtouch™ antimicrobial lin of healthcare textiles with SilverClear® the same as or similar to those described above. You should take prompt action to correct these violation(s). Failure to promptly correct these violation(s) 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.
Please submit a written response to this letter within 15 working days from the date you receive this letter describing your intent to comply with this request listing all promotional materials for SILVERtouch™ antimicrobial line of healthcare textiles with SilverClear® the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Pleas direct your response to Betty "Collins at the Food and Drug Administration W066-3512, 10903 Hew Hampshire Ave, Silver Spring, Maryland 20993; facsimile at 301-847-8137. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for SILVERtouch™antimicrobial line of healthcare textiles with SilverClear® comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and