FDA WARNING_LETTER - Argentum Medical LLC

On May 29, 2012, the FDA issued a Warning Letter to Argentum Medical, LLC, for marketing Silverlon wound and burn care products in the U.S. without required clearance or approval. The Office of Compliance reviewed Argentum's website on May 9, 2012, and found promotional claims for several cleared Silverlon products (e.g., Calcium Alginate Dressing, Wound Contact Dressing, Burn Contact Dressing) that exceeded their FDA-cleared intended uses.

Violations include claims such as "effective treatment against stubborn MRSA infections," "delivers a speedy and sustained kill against MRSA bacteria," "help wounds heal up to 50% faster," and "patients report significant pain reduction and reduced scarring." These claims render the devices adulterated under section 501(f)(1)(B) of the Act, as no approved premarket approval (PMA) or investigational device exemption (IDE) exists for these uses. The devices are also misbranded under section 502(o) for failure to notify the FDA of intent to introduce them into commercial distribution for these unapproved uses.

The FDA requested Argentum immediately cease marketing Silverlon products for unapproved uses. The firm must respond within fifteen business days with specific corrective actions, a plan to prevent recurrence, and documentation. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal