The FDA is providing guidance for devicemakers that want to coordinate development of antimicrobial susceptibility tests with sponsors developing antimicrobial drugs.
Coordinated development of antimicrobial drugs and antimicrobial susceptibility tests (ASTs) should not be construed as companion diagnostics, the FDA said in draft guidance issued on Sept. 21.
Rather, the guidance describes interactions between devicemakers and drug sponsors for coordinating development, as well as explaining considerations for submitting separate applications to CDRH and CDER.
The guidance notes that review of the drug and device components would remain independent and that coordinated development would not affect MDUFA and PDUFA user dates.
The guidance points out that AST devices that test for in vitro susceptibility of bacterial pathogens are often developed after antimicrobial drugs are approved, and that coordinating development of new antimicrobial drugs with AST devices could shorten the time for clearing the device.
In addition, drug sponsors could benefit by having access to the AST device technology during clinical trials, and devicemakers could benefit by having access to clinical samples and isolates obtained during the drug development process to help validate their devices.
Currently, a 510(k) premarket notification is required for an AST device launched for the first time, or for changes to a cleared device. Similarly, a 510(k) would also be required when seeking to add a new approved antimicrobial drug to an existing AST panel.
The FDA recommends that devicemakers and drug sponsors discuss coordinated development early on in the drug development process so that data to help develop AST devices could be generated during clinical trials.
Interactions don’t need to be restricted to a single devicemaker, the FDA says, stressing that the availability of a drug to multiple devicemakers for use during AST device development “may increase clinical laboratories’ access to AST devices at the time of drug approval or shortly thereafter.”
The guidance recommends that both the drug sponsor and devicemaker submit their coordinated development plans to CDER and CDRH for review.
An investigational device exemption may be needed if the AST device under development is to be used for clinical trial enrollment, and this should be discussed with CDRH through the pre-submission process, the guidance suggests.