- December 5, 2023
- 1:00 PM - 2:00 PM ET
On December 5, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested stakeholders to discuss the immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling.
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex, and costly public health problem. Critical to addressing the urgent public health threat of AMR is its detection. Antimicrobial susceptibility test (AST) system devices rely on interpretive criteria, also called breakpoints, for appropriate interpretation. The use of current, up-to-date, breakpoints are necessary to detect drug-resistant infections and guide clinicians to the selection of an efficacious antimicrobial. CDRH is addressing AMR by ensuring that antimicrobial susceptibility tests on the market provide accurate results for patient care.
This guidance describes an approach for AST system device manufacturers to update their susceptibility test interpretive criteria (STIC)/breakpoints in device labeling and describes an enforcement policy regarding applying such updates to AST system devices that were cleared without breakpoint change protocols (“legacy AST system devices”). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.
This guidance includes the FDA’s recommendations on the marketing submission content for predetermined change control plans (PCCPs) for new AST system devices, describes an enforcement policy for legacy AST system devices, and clarifies the process for incorporating by reference a cleared PCCP or breakpoint change protocol into a new 510(k) submission for an AST system device.
This guidance supersedes Sections II.A and V of the FDA’s Guidance Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (June 2009). With the publication of this guidance, the June 2009 guidance is fully superseded and being withdrawn as it no longer reflects current FDA policy.
The FDA encourages stakeholders to review the guidance and submit any questions about this guidance to ASTdevices@fda.hhs.gov.
After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under “In Vitro Diagnostics.”
If you have questions about this guidance document, please contact CDRH’s Division of Microbiology Devices at ASTdevices@fda.hhs.gov.
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.