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# Antimicrobial Drug and Susceptibility Test Guidance
- URL: https://www.fdaweb.com/antimicrobial-drug-and-susceptibility-test-guidance/
- Published: 2019-01-17T12:00:00.000Z
- Updated: 2026-09-15T00:55:01.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143170

FDA has released a final guidance, *Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices*, to assist drug or medical device sponsors who are planning to develop new drugs and test devices and want to coordinate development of the products so that the test device could be cleared either at the time of new drug approval or shortly thereafter. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM521421.pdf?ref=fdaweb.com) is intended to: 

- describe interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an antimicrobial susceptibility test (AST) device;
- explain the considerations for submitting separate applications to CDER and CDRH when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval; and
- clarify that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the MDUFA and PDUFA review timelines for either product.

The agency has scheduled a 2/12 90-minute Webinar on the guidance. Instructions for participating in the Webinar are [here](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm629587.htm?ref=fdaweb.com).