SUPPLIER FDA EVIDENCE WORKSHEET
FDADeviceCheck editorial worksheet - October 30, 2026
One establishment/device combination per worksheet. This is not an FDA form.

Review reference:
Retrieval date and time:

SUPPLIER CLAIM (verbatim):
Supplier document reference:
Establishment legal name:
Physical address:
Claimed role/activity:
FEI (label separately):
Registration number (label separately):
Device name:
Model/catalog number:
Product code, if available:
Claimed product decision/reference, if applicable:
Affected-item identifiers from a recall notice, if relevant:

OFFICIAL EVIDENCE (repeat for each record):
Source URL:
Record identifier:
Source date/update date, if shown:
Date retrieved:
Fields compared:
Matches:
Differences:
Unavailable information:

HANDOFF:
What is supported by the record:
What remains unresolved:
Next question:
Source or document needed to resolve it:
Reviewer/reference in your own process:

Registration or listing is not approval, clearance or authorization.
A missing record is not by itself a noncompliance finding.
Do not turn this worksheet into a safety, import or purchase approval.

Guide: https://fdadevicecheck.com/supplier-fda-evidence-checklist/
FDA source directory: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases