FDA Recognised Consensus Standards
Under FD&C Act § 514(c) and the associated regulation 21 CFR Part 898, FDA maintains a list of recognised consensus standards — voluntary national and international standards that FDA has determined are relevant to demonstrating safety and effectiveness of devices.
How recognised standards work
When a manufacturer demonstrates conformance to an FDA-recognised standard:
- FDA relies on that conformance to satisfy related regulatory requirements
- The manufacturer may submit a Declaration of Conformity rather than the full underlying test data (for the Abbreviated 510(k) pathway)
- FDA does not need to independently assess the test method — only the results
Searching the recognised standards database
FDA Standards Database — searchable by:
- Standard number (e.g., ISO 10993-1)
- Standard title keywords
- Product code
- Device specialty area
Commonly referenced standards
Quality and risk management
| Standard | Scope |
|---|
| ISO 13485:2016 | Quality management systems for medical devices |
| ISO 14971:2019 | Risk management for medical devices |
Electrical and mechanical safety
| Standard | Scope |
|---|
| IEC 60601-1 (Ed. 3.1) | Medical electrical equipment — general safety requirements |
| IEC 60601-1-2:2014 | Electromagnetic disturbances (EMC) |
| IEC 60601-1-6 | Usability/human factors |
Software
| Standard | Scope |
|---|
| IEC 62304:2006+A1:2015 | Medical device software lifecycle processes |
| IEC 62366-1:2015 | Usability engineering for medical devices |
Biocompatibility
| Standard | Scope |
|---|
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5, -10, -12 | Cytotoxicity, sensitisation, sample preparation |
Sterilisation and packaging
| Standard | Scope |
|---|
| ISO 11135:2014 | Sterilisation of health care products — Ethylene oxide |
| ISO 11137 | Sterilisation by radiation |
| ISO 11607-1:2019 | Packaging for terminally sterilised medical devices |
Official resources