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 help FDA establish a denominator (total devices distributed) for calculating adverse event rates and identifying 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
Official resources
Resubmit a baseline report when: (1) the device model is discontinued and replaced with a new model; (2) the manufacturer relocates or changes; (3) the number of distributed units increases or decreases by more than 50% from the previously reported figure; or (4) significant design changes are made that alter the device's risk profile. Minor labelling updates or small distribution volume fluctuations typically do not require baseline report updates.