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How Diagnostic Devices Help Address Antimicrobial Resistance and CDRH’s Role in Bringing Antimicrobial Susceptibility Tests to Market

Today, the U.S. Food and Drug Administration (FDA) launched a new webpage to explain how antimicrobial susceptibility test devices are intended to help health care providers identify the correct therapy (antimicrobial agent) to treat specific bacterial or fungal infections and help identify drug-resistant infections for patient care. Antimicrobial susceptibility testing devices sold in the U.S. for use in clinical laboratories must be reviewed and cleared by the FDA’s Center for Devices and Radiological Health (CDRH).

Facts about the new webpage

The new webpage is intended to:

• Explain CDRH’s role in addressing antimicrobial resistance
• Provide an up-to-date resource for interested stakeholders
• Highlight the FDA and CDRH collaborations to proactively combat antimicrobial resistance

Questions?

If you have questions about the new webpage, contact the Division of Industry and Consumer Education.