Docket Number:
FDA-2016-D-2561
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-2561.