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# Coordinated Antimicrobial Drug, Test Development Guidance
- URL: https://www.fdaweb.com/coordinated-antimicrobial-drug-test-development-guidance/
- Published: 2016-09-20T12:00:00.000Z
- Updated: 2026-09-14T21:33:42.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136854

FDA has issued for comment a draft guidance, *Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices*, to assist drug sponsors and medical device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of the products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The [document](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM521421.pdf?ref=fdaweb.com) says it intends to: 

- describe interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an 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.