Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Medical Device Legislation Microbial Sensitivity Tests -- standards Product Labeling United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretive criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website (STIC Website). 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 supersedes Sections II.A and V of the FDA guidance “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices” issued in June 2009 (“June 2009 guidance”). As described in the June 2009 guidance, “updating the STIC will significantly affect the safety and effectiveness of the AST system device and, therefore, ordinarily would require submission of a premarket notification (510(k)) prior to updating device labeling.” In the June 2009 guidance, FDA described an enforcement policy where FDA would generally not object to device sponsors updating STIC in their AST system device labeling without a new 510(k) where the updated STIC did not affect acceptable device performance, as described in the “Antimicrobial Susceptibility Test (AST) Systems - Class II Special Controls Guidance,” and the only change to the AST system device labeling was updating STIC. While FDA interpreted this policy to also include breakpoint change protocols, as discussed further below, the June 2009 guidance did not describe the procedures for updating AST system device labeling when using a breakpoint change protocol. This guidance describes approaches for AST system device sponsors to update their STIC in device labeling via predetermined change control plans (PCCPs), and also describes an enforcement policy regarding applying such updates to AST system devices that were cleared without breakpoint change protocols. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health and the urgent public health need for sponsors to update breakpoints for legacy AST system devices. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages))
- NLM Unique ID:
- 9918716786206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716786206676