FDA’s New Breakpoints in Device Labeling

Oct 13, 2023 | News |

Introduction to the Guidance 

FDA issued a new guidance document “Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling”. The purpose of this guidance document, issued on September 29, 2023, is to inform industry of the updated susceptibility test interpretive criteria, or synonymously, breakpoints which have been posted on FDA’s Susceptibility Test Interpretive Criteria (STIC) website. Updating breakpoints is essential due to the changes in organism resistance patterns and treatments. The document aims to give device sponsors guidance on updating their STIC in device labeling through predetermined change control plans (PCCPs) and outlines a plan for implementation. 

Guidance Content 

The scope of this guidance pertains to devices classified in the table below:[2] 

Table 1: Scope of the guidance in terms of devices 

Establishing a PCCP 

AST system device manufacturers can proactively seek clearance for breakpoint updates to their device labeling without submitting another 510(k) by proposing a PCCP in the original 510(k) submission. Premarket authorization with a PCCP must be established through the 510(k) pathway. When determining equivalence to a predicate device, the subject device must be compared to the version that was cleared prior to changes made under the PCCP. Procedures in the established PCCP should ensure that the updates are consistent with the STIC Website and do not significantly change the device's performance. 

Utilizing a PCCP 

The PCCP should be implemented based on the manufacturer’s quality system and should be assessed through the lens of the existing risk management system. This allows manufacturers flexibility to update the STIC in the labeling of their AST system device, if the update is consistent with their cleared PCCP, without the need for a new 510(k) submission. The FDA believes this will allow for prompt updates and requests for updated labeling to be sent to ASTDevices@fda.hhs.gov. If the update is inconsistent with, or not included in the cleared PCCP, a new 510(k) must be submitted to FDA. Deviations from a cleared PCCP could affect the safety and performance of the device in which case the device is considered “adulterated and misbranded under sections 501(f)(1) and 502(o) of the FD&C Act”. 

Content of a PCCP 

The PCCP should show how the sponsor will evaluate the updated breakpoints and outline a procedure to demonstrate the use of these breakpoints. Existing data should uphold the clearance of the device by showing that its performance has been maintained in relation to the most recently cleared device. The evidence should also support that no new risk or changed existing risks are created through the updated breakpoints. Recommendations for a proposed PCCP framework are further laid out in the guidance. 

Application for Breakpoint Updates to a Cleared AST System Device (Legacy AST System Devices) 

Breakpoint change protocol helps ensure that updates are consistent with those recognized on the STIC Website and the updated device’s performance is maintained. A cleared PCCP still applies for devices with different indications for use because it has similar technological characteristics, same classification, same product code, and have the same intended uses. To mitigate risk of new issues, FDA suggests using: 

  1. Using a cleared PCCP protocol from the sponsor’s separate 510(k) 
  2. Breakpoint change protocol that is applied to the sponsor’s legacy AST system device 
  3. Both AST system devices under the same classification regulation, product code, and the same intended uses/characteristics 

Incorporation for a New 510(k) Submission 

For sponsors submitting a new 510(k) who want to leverage a cleared PCCP that was previously submitted in a 510(k), the sponsor should reference the cleared PCCP into the new 510(k) submission. The 510(k)-submission number or another form of reference should be shown to link the previous 510(k). 

Call to Action 

For those interested in learning more, FDA is hosting a webinar dedicated to this guidance. FDA encourages stakeholders to review and submit any questions on this guidance to ASTdevices@fda.hhs.gov. 

Webinar Information 

Webinar – “Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices – Updating Breakpoints in Device Labeling” 

Date: November 9.2023 

Time: 1:00 PM – 2:00 PM ET 

Link to FDA Website for more information: Webinar – Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices – Updating Breakpoints in Device Labeling – 11/09/2023 | FDA 

Do you have any questions about this guidance document or the upcoming webinar? MEDIcept has industry experts who can help. Contact us today at sales@medicept.com. 


[1] CDC. (2021, June 8). COVID-19 & Antibiotic Resistance | CDC. Www.cdc.gov. https://www.cdc.gov/drugresistance/covid19.html 

[2] Health, C. for D. and R. (2023, September 28). Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling. Www.fda.gov. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antimicrobial-susceptibility-test-ast-system-devices-updating-breakpoints-device-labeling 

CJ Stukel – Associate Medical Device Consultant