FDA MDR SOP + Reportability Worksheet — 21 CFR Part 803 (USA)

Process Package — Vigilance Reporting USA (FDA MDR)

Complete framework for FDA Medical Device Reporting under 21 CFR Part 803. Covers MDR reportability (death/serious injury caused or contributed to, plus the unique ‘malfunction recurrence’ criterion), 30-day standard timeline vs 5-day expedited reporting, eMDR submission via the FDA Electronic Submissions Gateway, and the §803.18 records retention requirements.

What’s included:

• SOP-VIG-US Vigilance Reporting USA — full procedure: MDR reportability per §803.50 (death, serious injury, reportable malfunction), 30-day reasonable investigation window per §803.56, 5-day expedited reporting triggers per §803.10(c), eMDR submission process, complaint handling integration, §803.18 recordkeeping.
• F-VIG-US.1 FDA MDR Reportability Decision Worksheet (Word) — three reportability questions per §803.3 (with the critical ‘malfunction recurrence’ test most often applied incorrectly), 30-day vs 5-day timeline determination, causality classification, device evaluation findings, peer review.

Why this package: The ‘malfunction that would likely cause/contribute to death or serious injury IF the malfunction were to recur’ criterion is where most non-reportable MDRs end up being reportable on FDA inspection. This worksheet forces the right test and creates the audit-ready rationale FDA expects.

Format: Microsoft Word
Updated: May 2026 — includes FDA QMSR (Feb 2026) integration
Delivery: Instant download after purchase