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# FDA Antimicrobial Susceptibility Test Guidance Explained
- URL: https://www.fdaweb.com/fda-antimicrobial-susceptibility-test-guidance-explained/
- Published: 2019-02-21T12:00:00.000Z
- Updated: 2026-09-15T01:06:27.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143442

An FDA final guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices intends to describe the interactions that are needed to achieve coordinated development of applications submitted to CDER and CDRH, according to CDRH Division of Microbiology Devices branch chief **Ribbi Shawar**. Speaking at a CDRH 2/12 [Webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm629587.htm?ref=fdaweb.com) on the guidance, Shawar said “the driver is to clarify the review of both the antimicrobial drug product and the antimicrobial AST device when independent and separate. So hence, the idea is coordinated and not necessarily co-linked.” He said it provides recommendations to the device and drug industries on working together to facilitate the time to clearance of AST devices by FDA.

The final guidance, Shawar said, clarified the process and timeline for coordinated development in AST devices. Also, between the draft and the final guidance, a flowchart was added depicting the recommended interaction between drug and device manufacturers and CDER and CDRH to facilitate coordinated development. Added to the final guidance, also, was information on its applicability to molecular devices.