Baseline Reports
The MDR baseline report requirement is a US-specific obligation with no direct equivalent in other major device regulatory frameworks.
What is a baseline report?
A baseline report (FDA Form 3417) is a report submitted by a manufacturer to establish a baseline MDR record for a specific device. Baseline reports were introduced to help FDA identify device-specific MDR trends.
When is a baseline report required?
Manufacturers must submit a baseline report when they submit the first MDR for a device — whether the first-ever MDR for that model, or the first MDR in a new calendar year for a device that has had prior MDRs.
A new or updated baseline report must be submitted when there are changes to the information previously reported (e.g., changes in device identification, significant changes in the number of devices distributed).
What the baseline report contains
- Device identification (manufacturer, brand name, model/catalogue numbers)
- 21 CFR Part and product code
- Premarket submission number (510(k)/PMA/De Novo)
- Approximate number of devices distributed domestically and internationally
- Date device became commercially distributed