FDA Device Label Review
A label review is a check of your device labeling, packaging and instructions for use against the requirements in 21 CFR Part 801.
You receive a marked-up version showing what complies and what does not.
It is done before you print, because a labeling error found after a print run is a disposal cost as well as a compliance cost.
A regulatory specialist prepares the review and a former FDA reviewer signs it. Both are named on the document you receive.
At a glance
| What it is | Your labeling checked against FDA requirements before production. |
|---|---|
| The regulation | 21 CFR Part 801 |
| What you receive | A marked-up review with every required element confirmed or flagged, and the correction for each. |
| What you send | Label artwork, carton artwork, and the instructions for use. |
| Turnaround | Confirmed when we quote. |
| Our fee | Quoted per device family. Send your artwork for a quote. |
What we check
- The statement of identity, and whether it matches the device as cleared or listed.
- Name and place of business of the manufacturer, packer or distributor.
- Adequate directions for use, or a valid basis for exemption from them.
- Prescription device statement, where the device is restricted to prescription use.
- The unique device identifier, where UDI applies to your device.
- Any symbols used, and whether a symbols glossary is provided.
- Storage, handling and expiry statements where they apply.
- Whether the indications for use match what FDA actually cleared. We read this from your clearance record in FDA's database, which is the version that governs.
A regulatory specialist prepares the review and a former FDA reviewer signs it. Both are named on the document you receive.
The error that causes the most trouble
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.