Health Care (regulated by US FDA)

Infection prevention specialists have long used silver as an effective antimicrobial for heath care and medical procedures such as wound care and topical disinfection. Silver demonstrates multiple mechanisms of action which make silver antimicrobials unlikely to promote antibiotic resistance. SmartSilver enhanced antimicrobial medical devices and antimicrobial health care products actively inhibit bacterial growth and show a 99+% reduction† in test microbes and common bacteria.

We have submitted a Device Master File (MAF) to the U.S. Food and Drug Administration (FDA) for a proprietary formulation of SmartSilver antimicrobial additives. The MAF provides technical, manufacturing and biocompatibility information about SmartSilver, facilitating the FDA review of antimicrobial treated medical devices and combination product candidates that reference the use of this SmartSilver additive.

This information is presented solely for FDA-regulated and international healthcare export purposes, and should not be considered for pesticidal, EPA-regulated applications.

† In vitro efficacy data are presented solely to substantiate the antimicrobial activity of silver additives.  Public health claims for medical devices require regulatory clearance by US FDA or appropriate international agency.