The reporting clocks
The reporting clocks: 30-day, 5-day, and 10-day — calendar vs working days, and who the clock starts with.
Free field guide · PDF
FDA Vigilance & MedWatch2026 Field Guide
The reporting clocks, the forms, and the practice — with the vigilance work you need.
- MDR clocks
- 30/5
- Form
- 3500A
- Part 803
- 21 CFR
Sourced from verified FDA publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified FDA publications.
The forms
The forms: MedWatch 3500A for mandatory reporting, 3500 for voluntary — plus eMDR electronic submission.
The practice
The practice: any-employee awareness, 'reasonably known' information, and the followup discipline.
Sources & scope
- fda.gov, General Instructions — For Form FDA 3500A MedWatch (for Mandatory reporting).
- mddionline.com, FDA's New MDR Regulations: What Manufacturers Need to Know.
- fda.gov, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA).
This guide is market-access intelligence, not regulatory or legal advice. FDA MDR reporting requirements, forms, and enforcement practice change — professional review is required before business use.
Market Access Strategy Session
Vigilance on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your post-market route — MDR clock design, eMDR setup, and vigilance-to-quality feedback loops.
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