The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto.
Table of Contents
The FDA, the US healthcare product regulatory authority, has released a guidance document on antimicrobial susceptibility test (AST) system devices.
This document outlines regulatory requirements and offers recommendations for compliance. It’s worth noting that these guidelines are not legally binding and do not create new rules or obligations.
The FDA also allows for alternative approaches that align with existing laws and have prior approval from the agency.
Introduction
The document serves as a guide for both the industry and the FDA staff on the matters related to susceptibility test interpretive criteria (STIC) or breakpoints and relevant performance data in the device labeling for antimicrobial susceptibility test (AST) system devices.
The changes come as a response to the updates presented on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website (STIC Website).
The main objective of this guidance is to ensure the rapid adoption of revised breakpoints in AST system devices, ensuring their safety and effectiveness.
The guidance acts as a replacement for the document issued earlier in June 2009, which discussed the updates of the STIC and its implications for AST system device’s safety and efficacy.
The FDA has now introduced methods for AST system device sponsors to update STIC in device labeling through Predetermined Change Control Plans (PCCPs) and has laid out an enforcement policy about updates to AST system devices that lacked breakpoint change protocols.
Moreover, this guidance has been put into place without public commentary, based on the urgent need for sponsors to address breakpoint updates for older AST system devices and the pursuit of public health.
The guidance documents issued by the FDA do not impose any legal responsibilities but offer the FDA’s perspective on a given topic.
Background
AST system devices help in determining the susceptibility of bacterial or fungal pathogens to different antimicrobial agents.
These devices are crucial for clinicians to decide on the right treatment strategy, as STIC helps interpret the AST results.
Over time, as new clinical and scientific data emerges about specific antimicrobials against particular bacteria or fungi, breakpoint recommendations might need adjustments.
Previously, updates in the AST system device labeling were delayed, often waiting for changes in the antimicrobial drug labeling.
Antimicrobial Resistance (AMR) is a significant health threat.
Statistics from the Centers for Disease Control and Prevention (CDC) in 2019 highlighted over 2.8 million antimicrobial-resistant infections annually in the U.S.
The COVID-19 pandemic further impacted the AMR situation.
As explained by the FDA, essential to combating AMR is early detection, and for that, AST system devices with updated breakpoints are to be used.
As further described in the guidance, the 21st Century Cures Act introduced a section allowing the FDA to recognize a consensus standard providing antimicrobial STIC or formulate alternative STIC.
The FDA thus created the STIC Website for such information.
The process was further streamlined by eliminating the need for new 510(k) submissions for devices with “breakpoint change protocols” since the STIC Website’s establishment in 2017.
Additionally, the Food and Drug Omnibus Reform Act of 2022 provided the FDA with the explicit authority to approve or clear PCCPs for devices requiring premarket approval or notification.
The guidance offers clarity on how to reference a cleared PCCP or breakpoint change protocol in a new 510(k) submission for an AST system device.
It is important to mention that the general aspects related to PCCPs are covered in a separate guidance document issued by the FDA.
Scope
The guidance specifically applies to devices classified under specific sections of the CFR and focuses on content expectations for PCCPs.
It does not provide recommendations for other modifications unrelated to updating breakpoints. In case of other modifications, consultation with relevant regulations and guidance is advised.
Manufacturers are encouraged to reach out to the Division of Microbiology Devices for any additional queries not covered in this guidance, especially regarding the applicability of the guidance for a specific device.
They are also urged to engage in discussions with CDRH for PCCP proposals in their marketing submission.
Conclusion
This guidance offers an overview of the current legal framework.
It also emphasizes essential factors for medical device manufacturers and other stakeholders to consider.
The recommendations aim to facilitate the timely incorporation of updated breakpoints into AST system devices.
Additionally, they prioritize safety, effectiveness, and relevance in the fight against antimicrobial resistance
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