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Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration

This guidance introduces the Safety and Performance Based Pathway as an optional pathway for demonstrating substantial equivalence in 510(k) submissions. It applies to well-understood device types where submitters can demonstrate that a new device meets FDA-identified performance criteria to prove it is as safe and effective as a legally marketed device, instead of direct comparison testing.

  1. Verify device type is listed as eligible for Safety and Performance Based Pathway on FDA website
  2. Identify appropriate predicate device and confirm:
    • Same intended use
    • No new safety/effectiveness questions from technological characteristics
  3. Review FDA guidance for specific performance criteria and testing methods for the device type
  4. Prepare submission including:
    • Required 510(k) elements per 21 CFR 807.87
    • Declaration of Conformity and/or test results demonstrating performance criteria are met
    • Appropriate documentation based on testing methodology used
  5. Consider seeking FDA feedback if unclear about eligibility or requirements
  6. Maintain awareness of any changes to device type eligibility or performance criteria
  7. Consider traditional 510(k) pathway as alternative if needed

Key Considerations

Non-clinical testing

  • Performance criteria must be met using appropriate testing methods
  • Testing methods can be either FDA-recommended or alternative methods
  • Results must be documented through Declaration of Conformity, results summary, testing protocols, and/or complete test reports depending on the testing methodology used

Labelling

  • Must provide labeling information as in traditional 510(k)
  • No direct comparison testing against predicate device required

Biocompatibility

  • Must provide biocompatibility information as in traditional 510(k)
  • No direct comparison testing against predicate device required

Safety

  • Device must have same intended use as predicate device
  • Technological characteristics must not raise different safety and effectiveness questions
  • Performance criteria must represent performance levels at least equivalent to legally marketed devices

Other considerations

  • 21 CFR 807.87: Content requirements for premarket notifications
  • 21 CFR 10.115: Good Guidance Practices

Original guidance

  • Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
  • HTML / PDF
  • Issue date: 2019-09-20
  • Last changed date: 2019-09-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket, Biologics
  • ReguVirta summary file ID: 40e74927ae0a24005c935c651c2d83e4
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