Capture the claim
Keep the supplier’s document and record what it claims about the establishment and the device.
Practical evidence guide · October 30, 2026
Build a supplier evidence packet you can retrace.
Collect the identifiers, official records and unanswered questions in one place before passing a supplier claim to the next reviewer.
Three steps
A packet another reviewer can retrace.
Find the official record
Follow the matching record type in the directory. Save its URL and the identifiers you compared.
Write the unresolved question
A missing field stays unresolved. A link to a record is evidence to examine, not a completed approval decision.
Reusable checklist
Supplier evidence worksheet
Use one worksheet per establishment and device combination. These are editorial prompts for organizing evidence, not FDA filing requirements.
- Establishment
- CollectLegal name, physical address and claimed role.
- Record carefullyKeep the supplier’s wording separate from the name and address in the official record.
- Identifiers
- CollectFEI and registration number, each labeled.
- Record carefullySave the source link for each number; do not substitute one type of identifier for another.
- Device
- CollectDevice name, model/catalog number and product code when available.
- Record carefullyA brand or establishment name alone is not an exact product match.
- Claimed decision
- CollectThe supplier’s 510(k), PMA, De Novo or other claimed reference, if applicable.
- Record carefullyVerify in the relevant FDA source and record the device and scope. Absence of a number is not, by itself, a noncompliance finding.
- Recall context
- CollectModel and the lot, serial or other affected-item identifiers in a notice.
- Record carefullyCompare to the item being reviewed; keep the notice link and its instructions with the record.
- Evidence trail
- CollectOfficial URL, record identifier, retrieval date and source date if shown.
- Record carefullyWrite what matched, what differed and what was unavailable; assign a next question instead of a pass/fail score.
Open blank worksheet (.txt)Plain text. Copy it or use your browser’s Save command. No information is submitted.
Worked example
Same brand, different establishment.
Fictional example. No real supplier, identifier or device is being checked.
What the supplier provides
“Example Brand” and a registration screenshot
The quotation names “Example Distributor”; the screenshot names “Example Manufacturer” at another address. No model number is supplied.
What to write in the packet
Relationship and device not yet confirmed
Keep both names and addresses. Ask which establishment performs the claimed activity, how it relates to the distributor, and which exact device the evidence concerns.
Do not label the supplier approved or rejected from this discrepancy alone.
Handoff
Finish with facts and open questions.
- Compared: identify the records and fields you actually checked.
- Unresolved: name the missing information or mismatch without filling the gap.
- Next action: state the question and which source or document could answer it.
- Time: record when you retrieved the evidence; recheck time-sensitive records before relying on them.
For affected products and lots, use the recall-record guide. For the existing lookup’s coverage, read the methodology.
Primary FDA sources
Sources and review date
Source documentation reviewed October 30, 2026. This date describes this guide, not a new check of any supplier or device.