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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.

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By ReguVirta
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What You Need to Know? 👇

What is the difference between FDA-recognized consensus standards and non-recognized standards in premarket submissions?

FDA-recognized consensus standards have been formally identified by FDA and assigned recognition numbers, allowing manufacturers to submit Declarations of Conformity (DOCs). Non-recognized standards can still be used generally but cannot support DOCs and require more supporting documentation.

When can I submit a Declaration of Conformity instead of providing complete test data?

You can submit a DOC when using FDA-recognized consensus standards that include both test methods and predefined acceptance criteria. Standards that are process-oriented, horizontal, or lack specific acceptance criteria typically require supplemental documentation per ISO/IEC 17050-2.

How do transition periods work when consensus standards are updated?

Transition periods allow continued use of older standard versions while preparing for newer ones. The transition period length is specified in the Supplemental Information Sheet (SIS), and after expiration, only the newer standard version will be accepted for DOCs.

Are promissory statements acceptable in premarket submissions for consensus standards?

Generally no. FDA expects conformance to consensus standards before submission. Promissory statements may be acceptable in limited cases for well-defined standards with clear acceptance criteria, but cannot be used with DOCs, which require prior conformance certification.

What happens to my device clearance if the consensus standard I used gets withdrawn?

Your cleared/approved device remains legally marketed and eligible as a predicate device. However, new submissions citing your device as predicate cannot use DOCs to the withdrawn standard and must use the current recognized version.

Do consensus standards alone satisfy all premarket submission requirements?

No. Consensus standards typically satisfy only portions of premarket submissions. Additional information may be required for safety/effectiveness evaluation, clinical data, or device-specific performance specifications not addressed by available consensus standards.

What You Need to Do 👇

  1. Verify if standards are FDA-recognized before using them in submissions
  2. Ensure testing is completed before submitting DOC
  3. Include all required elements in DOC documentation
  4. Maintain complete testing records in design history file
  5. Check FDA database regularly for standard updates and transitions
  6. Submit supporting documentation when using broad/general standards
  7. Avoid promissory statements about future conformance
  8. Consider early interaction with FDA when standards are changing during development
  9. Ensure conformance to current recognized version after transition periods expire
  10. 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 🔗

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 ID: 111d88e541b2167a1357cdc2ba08807d
FDA guidance, Final
Radiation-Emitting Products Medical Devices Postmarket Premarket Administrative / Procedural
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