Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
This guidance describes how to appropriately use and document both FDA-recognized and non-recognized consensus standards in medical device premarket submissions. It provides clarity on the regulatory framework, policies and practices for utilizing consensus standards during the review process. The guidance applies to all articles meeting the device definition under section 201(h) of the FD&C Act.
Recommended Actions
- Verify if standards are FDA-recognized before using them in submissions
- Ensure testing is completed before submitting DOC
- Include all required elements in DOC documentation
- Maintain complete testing records in design history file
- Check FDA database regularly for standard updates and transitions
- Submit supporting documentation when using broad/general standards
- Avoid promissory statements about future conformance
- Consider early interaction with FDA when standards are changing during development
- Ensure conformance to current recognized version after transition periods expire
- Remember standards conformance alone may not satisfy all premarket requirements
Key Considerations
Non-clinical testing
- Testing should be conducted on final finished device when possible
- If testing is not done on final finished device, justification must be provided for any differences
- Testing can be performed in-house or by third party labs/certification bodies
- Records of testing must be maintained as part of design history file
Other considerations
- Declaration of Conformity (DOC) must include specific elements like product identification, statement of conformity, standards list, FDA recognition numbers, etc.
- Supporting documentation may be required for certain broad standards
- Transition periods are provided when standards are updated to allow continued use of older versions
- Promissory statements (indicating future conformance) are generally not acceptable
- Standards conformance typically only satisfies a portion of premarket requirements
- Falsifying a DOC is prohibited and makes the device adulterated
Relevant Guidances
- Recognition and Withdrawal Process for Voluntary Consensus Standards
- Design Controls for Medical Device Manufacturers
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms
- ISO/IEC 17050-1: Conformity assessment – Supplier’s declaration of conformity – Part 1: General requirements
- ISO/IEC 17050-2: Conformity assessment – Supplier’s declaration of conformity – Part 2: Supporting documentation
Original guidance
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- HTML / PDF
- Issue date: 2018-09-14
- Last changed date: 2020-10-20
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, Postmarket, Premarket, Administrative / Procedural
- ReguVirta summary file ID: 111d88e541b2167a1357cdc2ba08807d
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