FDA 510(k) Labeling Requirements: What Must Be in Your Submission
Labeling deficiencies are the number one cause of Refuse to Accept decisions. Here's exactly what FDA requires in your 510(k) labeling — and how to make sure it's consistent across your entire submission.
FDA's 510(k) regulations require proposed labeling to be included in the submission. Labeling deficiencies are the most common cause of Refuse to Accept (RTA) decisions — administrative rejections that reset your review clock before FDA has even begun substantive review. Getting labeling right is one of the highest-leverage things you can do before filing.
What counts as labeling
FDA defines "labeling" broadly. For 510(k) purposes, labeling includes:
Required labeling elements under 21 CFR Part 801
The general device labeling requirements under 21 CFR Part 801 require the following elements. Final labeling must be "adequate" — all required elements present, accurate, and consistent with the rest of your submission:
- Device name — the established name (common or usual name) plus any proprietary name
- Manufacturer name and place of business — the responsible party for the device
- Intended use / indications for use — what the device is intended to do, for whom, and in what clinical context
- Directions for use — how to use the device, including preparation, operation, and any required training
- Warnings and precautions — contraindications, warnings about specific patient populations, precautions for use
- Adverse reactions — known adverse reactions associated with the device or procedure
- Symbols — any symbols used on the device or packaging must be from a recognized standard (ISO 15223) or explained in the IFU
The intended use consistency requirement
The single most important labeling requirement for 510(k) purposes is consistency. The intended use statement in your labeling must be identical to the intended use statement in Section 1 of your eSTAR, which must match the Indications for Use form, which must be consistent with the predicate comparison in Section 4.
Any variation — even minor wording differences — between the intended use in labeling and the intended use in other sections of the submission creates an inconsistency that FDA will flag. A common mistake is writing the intended use in the IFU in clinical language and writing it in regulatory language for Section 1, resulting in a mismatch that triggers either an RTA or an AI request.
Draft labeling is acceptable
FDA accepts draft labeling in a 510(k) submission. You do not need final, print-ready labeling to file. The labeling must be complete — all sections present, all required elements included — but formatting, fonts, and layout may change post-clearance. What must be final: the intended use statement, indications, contraindications, warnings, and precautions. These cannot change materially post-clearance without a new 510(k) or a labeling change supplement.
Common labeling RTA triggers
- Missing labeling entirely — no IFU, no device label, or no carton label when all are required
- Indications for Use form mismatch — the Indications for Use form (a separate eSTAR attachment) does not match the intended use in the IFU
- Missing manufacturer address — the physical address of the manufacturer must appear on the device label
- Undefined symbols — using symbols not from ISO 15223 without defining them in the IFU
- No contraindications — even if there are no contraindications, the IFU must include a section stating this explicitly
- Expanded indications in labeling — labeling that implies a broader use than what is supported by the predicate and performance data
FDA 510(k) summaries and summaries of safety and effectiveness often describe predicate labeling. Search cleared devices in your product code to understand what FDA has accepted.
Start free trial →