Publicly visible regulatory timing from US Food and Drug Administration breakpoint updates to automated antimicrobial susceptibility test clearances: a longitudinal database study, 2017-2026
Zilin Li, Xiaoxiao HeAbstract
Objectives
Updated antimicrobial susceptibility testing (AST) breakpoints require implementation in laboratory systems, but the timing of device updates across revisions has not been quantified. We measured publicly visible intervals from US Food and Drug Administration (FDA) breakpoint actions to clearances for established automated AST platforms.
Methods
Drug-specific FDA breakpoint actions from January 1, 2017, through August 23, 2026, were linked to 510(k) decision summaries for MicroScan, VITEK 2/VITEK 2 Compact, and BD Phoenix when the public record supported the drug, organism group, platform, and updated breakpoint relationship. Total lag was decomposed into breakpoint-to-receipt submission lag and receipt-to-decision FDA review interval.
Results
Eighty-nine FDA notice rows yielded 22 eligible breakpoint events. Among 103 screened decision summaries, 13 clearances supported 18 links; 16 primary links involving 11 unique clearances and 10 events met prespecified criteria. Median total lag was 22.3 months (interquartile range, 9.1-42.0; range, 0.1-59.7), median submission lag was 13.3 months (interquartile range, 5.7-32.8), and the median review interval among unique clearances was 6.9 months (interquartile range, 3.1-7.7). Three submissions were received before the corresponding breakpoint action. No qualifying public link was identified for 12 events, but this cannot establish outdated labeling because cleared change protocols may permit updates without another 510(k).
Conclusions
Public 510(k) records show heterogeneous breakpoint-to-clearance intervals, with a longer prereceipt than review component. A dated, machine-readable registry of breakpoint-related labeling changes would improve transparency, including for updates made without a new 510(k).