Insights for Medical Device Professionals

A comprehensive reference for RA/QA professionals on FDA post-market surveillance requirements — covering MDR reporting (21 CFR 803), complaint handling, CAPA, trend analysis, and QMSR 2026 changes.

This week’s FDA external signals reinforce a familiar RA/QA reality: your audit risk isn’t “missing a recall headline”—it’s failing to prove you reviewed it, assessed relevance, and recorded a decision. A high-quality external PMS system must produce: (1) a clear signal list, (2) relevance triage + rationale, (3) timestamps (Published/Captured/Reviewed), and (4) an exportable evidence pack.

This week saw 12 new FDA device recalls including 3 Class I events, plus Health Canada updated 47 medical device listings. Here is what your RA/QA team needs to know.

External PMS means monitoring publicly available regulatory signals for events related to your device. Here is what the standards require and how to build an audit-ready evidence system.

By TrueMedDevice Team · Mar 25, 2026 · 5 min read | Today's FDA enforcement actions expose critical gaps in labeling adequacy, software validation, and supplier quality management that could trigger regulatory scrutiny across device categories.