The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to antimicrobial susceptibility test (AST) system devices in the context of updating breakpoints in device labeling.
The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
Regulatory Background
The Antimicrobial Susceptibility Testing (AST) system devices are vitally important for effective patient treatment since they provide data about the susceptibility of bacteria and fungi to antibiotics and antifungals, respectively.
Furthermore, the Susceptibility Test Interpretative Criteria (STIC) of an AST system device plays a key role in its efficiency and reliability.
As explained by the FDA, any update to the STIC can significantly influence the device’s safety and effectiveness.
Thus, the FDA has issued guidance on incorporating updated breakpoints in AST system device labeling without a cumbersome process using the Predetermined Change Control Plan (PCCP).
It is important to mention that the general matters associated with the concept of a PCCP are addressed in detail in a separate guidance document issued earlier by the FDA.
In general, the use of a PCCP provides that the changes described therein would not require a new marketing submission in order to be implemented.
The Importance of Establishing a PCCP
A PCCP allows AST system device manufacturers to specify in advance and seek clearance for breakpoint updates to their device llabelling.
This is valuable as, without a PCCP, any such change would typically necessitate another 510(k) submission. In line with the recommendations provided by the authority, every AST system device 510(k) submission that lacks a PCCP should propose one in any subsequent submissions.
This proactive approach promotes the swift adoption of breakpoint updates.
To obtain premarket authorization for an AST system device with a PCCP, it must be cchannelledthrough the 510(k) pathway.
This ensures the PCCP is evaluated and approved as an essential component of the 510(k) for the device.
In situations where an equivalence determination is essential, and the predicate device was approved with a PCCP, a comparison is made with the version of the predicate device that was cleared before any PCCP-triggered changes.
Components of a PCCP
The guidance further outlines the key components to be included in the said plan.
According to the document, the PCCP should have clear procedures ensuring that any updates to the breakpoints align with those recognized on the STIC Website.
Such alignment guarantees that there’s no significant alteration in the performance of the updated device compared to its most recent cleared version.
When a PCCP gets approval in a 510(k) for an AST system device, it becomes an intrinsic part of the 510(k) clearance.
The PCCP should be evaluated within the risk management framework of the device and should align with the manufacturer’s quality system.
If the STIC update complies with the approved PCCP, the sponsor can refresh the STIC in their AST system device labeling without forwarding a new 510(k) submission to the FDA.
However, it is important to mention that if the STIC update deviates from the approved PCCP, the sponsor should evaluate the modification in line with relevant FDA authorities and guidance.
Depending on the evaluation, a new 510(k) might be necessary.
As it was mentioned before, deviations from an approved PCCP during breakpoint updates can compromise the device’s safety and performance.
For instance, non-adherence to the PCCP when updating breakpoints could result in compromising the device’s clinical functionality.
In most cases, such deviations necessitate a 510(k) submission before updating the device labeling.
Content Specifications for a PCCP
A comprehensive PCCP should clarify how the sponsor will evaluate updated breakpoints and the methodologies employed to validate that the application of these updated breakpoints won’t compromise the device’s performance.
For AST system devices cleared without a PCCP or breakpoint change protocol, the FDA aims to streamline their labeling updates based on recognized breakpoint modifications.
The essence is to ensure the device’s safety and effectiveness are maintained.
Under the general rule, the FDA allows the use of an approved PCCP for legacy devices under the same classification, provided they share similar technological characteristics.
Conclusion
The present guidance intends to simplify and streamline the process of updating breakpoints in AST system device labeling.
By encouraging the establishment and utilization of PCCPs, the FDA intends to expedite the updating process, ensuring that these devices remain effective, safe, and relevant in the dynamic world of healthcare impacted by rapid technology development.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
