Post

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.

  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

  • 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
This post is licensed under CC BY 4.0 by the author.