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Antimicrobial Agents: FDA Requirements

The scope of characterization and evaluation of the device containing an antimicrobial agent depends on the type of antimicrobial, the device indications for use, and any predicate devices using the same, or similar, antimicrobial technology. The antimicrobial technology supplier should be able to provide the product design, experimental design, formulation development, analytical and performance testing, and data interpretation support to fulfill the FDA requirements for medical devices containing antimicrobials.

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."

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