I’ve shepherded several Class II devices through the 510(k) gauntlet and reviewed enough reviewer comments to notice a pattern: approvals rarely fail because a device “doesn’t work.” They stall because the submission doesn’t tell a clear, evidence-backed story. Below are the weak links I keep seeing — concrete, fixable problems that turn reviewer questions into hold letters and extra testing cycles.
The core problem: a disconnected story
FDA reviewers are looking to connect three things: intended use/indications, design and risk controls, and objective evidence (bench, software, biocompatibility, human factors, clinical when needed). When those links are missing, reviewers raise issues.
Common symptom list:
Vague intended use or inconsistent labeling across documents.
