Antimicrobial Agents: FDA Requirements

The typical range of information and support that should be provided includes:

?    Indications for use, relative to the antimicrobial component of the devices.
?    Identification and characterization of the device with antimicrobial agent relative to existing predicate devices.
?    Identification and detailed description of the antimicrobial chemistry and any adjuvant components.
?    Concentration of the antimicrobial agent and a description of the method of determination.
?    A detailed description of the method of application to the device including parameters and specifications.
?    The mechanism of action of the antimicrobial agent on, or in the vicinity of, the device when in use.
?    Information on the antimicrobial activity spectrum of the agent, particularly with respect to the relevant organisms that would interact with the device in use.
?    Description and characterization of the release mechanism and release kinetics from the device, including data generated from finished devices and a description of the validated methods used and limits of detection.
?    For noneluting antimicrobial agents, data should demonstrate that the agent is permanently bound to the device.
?    For eluting agents, information should be provided on the antimicrobial's distribution kinetics and rate of accumulation in the body.
?    Characterization of the minimum concentration of the antimicrobial agent that shows efficacy and a description of the methods used to determine this concentration under conditions of device use.
?    An evaluation of the toxicity of the antimicrobial, metabolites, and degradation products in the body.

Return to the main article, "Protecting Devices with Silver-Based Antimicrobials."