Life Sciences

FDA addresses devices with antimicrobial agents

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 20, 2007

Draft guidance from the FDA says the risk of including antimicrobial agents on devices should outweigh risks of increased resistance to the agents. The guidance helps the device industry prepare pre-market notification submissions for devices that include antimicrobial agents.

With that in mind, the guidance indicates pre-market notification should explain the rationale for adding the antimicrobial agent to a device, including the targeted bacterial species. It should also weigh the antimicrobial agent's effect on "emergence of resistant microbial strains" against the benefits of adding the antimicrobial agent to the device.

The guidance applies to devices containing antimicrobial agents and combination products that include antimicrobial drugs if the "primary mode of action is that of a device."

Device manufacturers should also provide detailed descriptions of the device with the added antimicrobial agent and the agent's characterization and formulation.

Other issues to address include:

  • Concentration of the agent in or on the device and the minimum effective concentration
  • Information about how the agent is added to the device and how the antimicrobial effect will be activated
  • Information about toxicity of the agent

    Finally, the guidance also provides advice on what information should be supplied in the labeling for the device.

    Comments on the proposal may be submitted by October 17, 2007.

    To view the draft guidance, click here.

    To read the Federal Register notice, click here.

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