FDA adds breakpoint updates to antimicrobial susceptibility test system device labeling guidance
The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates through the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria (STIC) website.The final guidance, released on 28 September 2023, contains recommendations and expectations for the content of marketing submissions for predetermined change control plans (PCCPs) that reference AST system device labeling updates, but does not provide recommendations for other AST system device planned modifications, such as those not related to breakpoint updates. The guidance provides a “least burdensome” approach for manufacturers to update their AST system device labeling, according to the agency.
This guidance, together with 2017 guidance on labeling of susceptibility test interpretive criteria, supersedes FDA’s 2009 guidance, “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.”
The final guidance is intended for devices that fall under 21 CFR 866.1640, 21 CFR 866.1645, or 21 CFR 866.1650, which include products involving antimicrobial test powers, antimicrobial test cards, and antimicrobial susceptibility tests; manual antimicrobial susceptibility tests, antifungal susceptibility test plates, short incubation antimicrobial susceptibility test systems, and positive blood culture identification and AST kits. The guidance does not apply to antimicrobial susceptibility test discs that fall under 21 CFR 866.1620.
PCCPs
Establishing a PCCP within a 510(k) pathway allows medical device manufacturers to incorporate breakpoint updates within the 510(k) pathway submission without the need for submitting another 510(k), the final guidance states.
“FDA recommends that all AST system device 510(k) submissions that do not already have an applicable PCCP include a proposed PCCP in any future 510(k) submission to facilitate the adoption of breakpoint updates in AST system device labeling,” the agency wrote.
The PCCP should include “procedures to help ensure that updates to the breakpoints consistent with those recognized on the STIC Website do not significantly change the performance of the updated AST system device,” FDA wrote. When breakpoint updates deviate from what has been cleared in a PCCP, it can cause alterations in the effectiveness and safety of a device, FDA said, such as a compromise in the device’s clinical functionality or performance.
FDA recommends that a PCCP contain a description of how sponsors will evaluate breakpoints, how they will use updated breakpoints, how they will apply breakpoints to existing data that supports the device’s clearance, and how they will demonstrate that the device is maintaining proper performance compared with an existing version of the cleared device. Sponsors should also include data supporting that the new breakpoints are not creating “new risks or significantly modify existing risks such that prior submission of a 510(k) would otherwise be required,” FDA wrote.
For legacy devices where a PCCP was not included in a 510(k) submission, FDA said it intends to work with sponsors to update their AST system device labeling, but noted that some legacy devices may need to submit a 510(k) if updating the STIC “could significantly affect the safety and effectiveness of the device.”
“At this time, FDA does not intend to object if a sponsor chooses to utilize a PCCP or breakpoint change protocol that has been cleared as part of a sponsor’s separate 510(k) to implement breakpoint updates for the sponsor’s legacy AST system device that is under the same classification regulation and product code and has the same intended use and the same technological characteristics (e.g., same instrument(s) or device design) as the device for which the protocol was cleared by FDA without submitting a 510(k) prior to making STIC labeling updates,” the agency wrote.
Guidance
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