FDA Guidance Synchronizes Launch of Antimicrobial and AST Device

The US Food and Drug Administration (FDA) has now released final guidance on how to synchronize development of antimicrobials and antimicrobial susceptibility test (AST) devices, according to Ribhi Shawar, PhD, ABMM, FAM, branch chief at the Division of Microbiology Devices, in the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health.

In a webinar on February 12, Dr. Shawar presented an overview of some key features of the new guidance.

AST devices are products used to help identify which specific antimicrobial agents a particular pathogen is sensitive to. Although these devices are useful to help guide clinicians in appropriate selection of antimicrobials at the patient level, they can also help to detect emerging drug resistance and monitor overall antimicrobial susceptibility changes. As such, AST devices play a role in combating the growing threat of antimicrobial resistance.

Although the FDA regulates AST devices, Dr. Shawar noted that they follow a different pathway to market than the drugs do.

And although increasing numbers of antimicrobials are more quickly reaching the drug approval stage, AST device development has not kept pace, and the devices frequently are not cleared until long after the drug is approved.

This delay in approving AST devices can impact patient care because a lack of susceptibility testing data may prevent clinicians using newly-approved antimicrobial agents that might more appropriately treat a patient’s multidrug-resistant organism infection.

The new guidance document aims to reduce this delay, said Dr. Shawar, by helping drug companies and medical device manufacturers to synchronize the processes to allow simultaneous approval of an antimicrobial and its corresponding AST device.

In particular, the document discusses how the two industries can interact to coordinate development of a new antimicrobial drug and its corresponding AST device. It also describes the important factors to consider when submitting applications for the 2 products, with a goal of simultaneous approval.

Overall, the FDA now wants more coordination in the early development stages, and the guidance specifically recommends that medical device companies should submit a 510(k) for their AST device about 4 to 5 weeks before the antimicrobial is expected to be approved.

However, the document also emphasizes that FDA will continue to independently make review decisions for AST devices and antimicrobial drugs, added Dr. Shawar. Existing regulatory requirements and timelines for drug or device review and approval or clearance remain unchanged, he said.

In concluding, he stressed how improved coordination of these two development processes has better synchronized the approvals of an antimicrobial and its corresponding AST device.

Before coordinated development activities, the time between antimicrobial approval and AST device clearance could be up to 40 months. However, since introducing coordinated development, this timeline has significantly decreased to 1 to 2 months, said Dr. Shawar.

This earlier availability of AST devices will help to improve both patient care and antimicrobial stewardship, he said.