510(k) Submission Contents & Checklist
A 510(k) must contain sufficient information for FDA to determine substantial equivalence. Incomplete submissions are the most common reason for Refuse to Accept (RTA) decisions.
Required elements (Traditional 510(k))
| Section | Description |
|---|---|
| Device description | Physical description, components, accessories, models/sizes |
| Intended use / Indications for use | Statement of intended use for the US market |
| Predicate device identification | K-number, device name, manufacturer, intended use |
| SE comparison | Side-by-side comparison of intended use and technological characteristics |
| Performance testing | Bench test data, biocompatibility (ISO 10993), EMC, sterility/packaging |
| Labelling | Draft label, IFU, carton labelling |
| 510(k) Summary or Statement | Either a public summary or a statement that safety/effectiveness data is available for review |
| Truthful and Accurate Statement | Certification that submission is truthful and accurate |
| Class III certification (if applicable) | For Class III preamendments devices |
Performance testing by device type
| Device category | Typical testing required |
|---|---|
| All devices | Risk analysis (ISO 14971), labelling review |
| Implantable devices | Biocompatibility (ISO 10993), mechanical testing, fatigue |
| Active devices | Electrical safety (IEC 60601), EMC (IEC 60601-1-2) |
| Software-containing devices | Software documentation (IEC 62304, FDA software guidance) |
| IVD devices | Analytical and clinical performance studies |
| Sterile devices | Sterility and packaging validation (ISO 11135, ISO 11607) |
| Devices with human/animal tissue | Additional testing for tissue-derived materials |
The Refuse to Accept (RTA) checklist
FDA performs an acceptance review within 15 business days of receiving a 510(k). Common RTA reasons include:
- Missing Indications for Use form (FDA Form 3881)
- No truthful and accurate statement
- Missing 510(k) Summary or Statement
- Incomplete SE comparison
- Missing required performance testing
- Draft labelling not provided
- Submission not in eSTAR format (required from October 2023)
eSTAR — the mandatory submission format
Since October 2023, all Traditional and Abbreviated 510(k)s must use eSTAR (Electronic Submission Template And Resource). eSTAR is an interactive PDF that guides submitters through the required content sections.
See eSTAR Templates for more detail.