Recognised Consensus Standards List
FDA maintains a searchable list of recognised consensus standards — international and national voluntary standards that FDA accepts as evidence of conformance to regulatory requirements.
Searching the FDA Standards Database
accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
Search options:
- By standard number (e.g., ISO 10993-1)
- By keyword (e.g., biocompatibility, sterilisation)
- By product code
- By specialty area (cardiovascular, orthopaedic, IVD, etc.)
Each result shows: standard title, edition recognised by FDA, product codes it applies to, and submission types where it is relevant.
How to use recognised standards in submissions
Abbreviated 510(k)
In an Abbreviated 510(k), you may substitute a Declaration of Conformity to a recognised standard for submission of detailed test data. Your Declaration must:
- Identify the specific standard and edition
- State that the device conforms to the standard
- Provide a summary test report (not the full data package)
- Certify that full records are available for FDA inspection
Traditional / Special 510(k) and PMA
Recognised standards can also be used in Traditional and PMA submissions — include the Declaration of Conformity and summary results in the performance testing section.
Key recognised standards by category
| Category | Standard | Edition recognised |
|---|---|---|
| QMS | ISO 13485 | 2016 |
| Risk management | ISO 14971 | 2019 |
| General electrical safety | IEC 60601-1 | 3rd edition + A1:2012 |
| EMC | IEC 60601-1-2 | 4th edition (2014) |
| Usability/HF | IEC 62366-1 | 2015 |
| Software lifecycle | IEC 62304 | 2006 + A1:2015 |
| Biocompatibility (general) | ISO 10993-1 | 2018 |
| Cytotoxicity | ISO 10993-5 | 2009 |
| Sensitisation | ISO 10993-10 | 2021 |
| EO sterilisation | ISO 11135 | 2014 |
| Radiation sterilisation | ISO 11137-1 | 2006 + A2:2019 |
| Sterile packaging | ISO 11607-1 | 2019 |
| Cleanroom classification | ISO 14644-1 | 2015 |
When a standard is not on the FDA recognised list
If you use a standard not on the recognised list, you cannot use the Abbreviated 510(k) pathway for that standard. However, you may still reference it in a Traditional 510(k) or PMA with the full supporting data, explaining the relevance and applicability.