FDA Device Label Review
Your labeling, checked against 21 CFR Part 801 before you print.
Label artwork, carton artwork and the instructions for use, read against the requirements and against the clearance you actually hold. You receive a marked-up version showing what complies and what does not.
A labeling error found after a print run is a disposal cost as well as a compliance cost. Draft artwork is fine — the earlier it arrives, the cheaper every finding is to fix.
- The regulation
- 21 CFR Part 801
- You send
- Artwork and the IFU
- Checked against
- Your clearance record
- You get back
- A marked-up review
- Signed by
- A named specialist
- Our fee
- Quoted per device family
Eight elements, on three documents.
Required elements are spread across the label, the carton and the instructions for use, which is why all three are read together rather than one at a time.
Statement of identity
Whether it matches the device as cleared or as listed.
Indications for use
Whether they match what FDA actually cleared, read from your clearance record rather than from your own file.
Name and place of business
Of the manufacturer, packer or distributor, as the regulation requires it.
Directions for use
Adequate directions, or a valid basis for exemption from them.
Prescription statement
Where the device is restricted to prescription use.
Unique device identifier
Where UDI applies to your device, and whether the label carries it.
Symbols and glossary
Any symbols used, and whether a glossary explaining them is provided.
Storage and handling
Storage, handling and expiry statements, where they apply.
Indications that go beyond what was cleared.
A company wins clearance for a defined intended use, then writes marketing language on the carton that describes a broader one.
For use by a trained healthcare professional. Adults only.
For use by a trained healthcare professional or by the patient at home. Adults and children over 12.
Two added phrases, and the device is now labeled for a use FDA did not clear. The clearance does not cover the labeled use, and the labeling itself is the evidence of the violation.
An illustration of the pattern, not a real device.
In our work, this happens most often when marketing copy is written by a different team from the one that prepared the submission, and nobody compares the two documents side by side. That comparison is the first step in this review, and we read the cleared wording from your clearance record in FDA’s database rather than from your own file — that is the version that governs.
Exempt from 510(k) is not exempt from Part 801.
A great many Class I devices never go through premarket notification, and their makers reasonably conclude that FDA has no view on them. The exemption is narrower than that. It removes one submission, and leaves everything else where it was.
Labeling requirements do not depend on how your device reached the market. They apply to exempt devices exactly as they apply to cleared ones.
The premarket notification submission, and the user fee that goes with it.
| What it does not touch | Still owed |
|---|---|
| Labeling | 21 CFR Part 801, in full |
| Establishment registration | Annual, with its own FDA fee |
| Device listing | Under the correct product code |
| UDI | Where it applies to your device |
A marked-up file, and what each finding should say instead.
You send three files. Label artwork, carton artwork, and the instructions for use.
A marked-up review
Every required element confirmed or flagged, against your actual artwork.
The correction for each
Not just what is wrong. What it should say instead.
Findings in priority order
Which are urgent, and which can wait for the next print run.
A named signature
Prepared and signed by a regulatory specialist with 10 to 25 years of experience.
Send the artwork while it is still a file, not a pallet.
- Quoted per device family
- Draft artwork accepted
- Checked against your clearance
- A named signature
At a glance
| What it is | Your label, carton and instructions for use checked against FDA requirements before production. |
|---|---|
| The regulation | 21 CFR Part 801 |
| What you send | Label artwork, carton artwork, and the instructions for use. |
| What you receive | A marked-up review with every required element confirmed or flagged, and the correction for each. |
| Also worth checking | Your UDI record, if the label carries an identifier. The label and the record have to agree. |
| Turnaround | Confirmed when we quote. |
| Our fee | Quoted per device family. Send your artwork for a quote. |
Questions people ask
Do we need this if our device is exempt from 510(k)?
Yes. Labeling requirements apply to exempt devices. Exemption from premarket notification is not exemption from Part 801.
Can you review labeling in another language?
We review the English labeling used for the United States market. If your artwork is multilingual, send the whole file and we review the English content within it.
What if the review finds our current labeling is wrong?
You receive the correction for each finding, in the order of priority. What you do next is your decision, and we will tell you which findings are urgent and which can wait for the next print run.
When should we send the artwork?
Before it goes to print. Draft artwork is fine, and earlier is cheaper: a correction made in the file costs you an amendment, and the same correction found after a print run costs you the print run.
Do you review the instructions for use as well as the carton?
Yes. Labeling means the label, the carton and the instructions for use, and the required elements are spread across all three. Send all of them together so we can see which document carries what.
Do we need a symbols glossary?
If you use symbols on the labeling, a reader has to be able to find out what they mean. We check which symbols you have used and whether a glossary explaining them is provided.
Our device is not cleared yet. Can you still review the labeling?
Yes, for everything except the indications comparison. That one is a check against your clearance record, so it needs a clearance to compare against. For a device still in development we review the required elements and flag the indications wording to be re-checked once the clearance issues.