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General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations

This guidance outlines FDA's principles for determining when a specific indication for use can be considered within a general indication for use of a medical device for substantial equivalence purposes. It helps manufacturers understand when adding specific indications might trigger the need for a PMA instead of a 510(k).

  1. Evaluate if the specific indication falls within accepted parameters of general use as defined by the clinical community
  2. Assess whether the specific indication:
    • Involves diagnosis/therapy of particular disease entities
    • Presumes specific clinical outcomes
    • Provides new diagnostic/therapeutic options impacting patient management
  3. Review available evidence and knowledge base supporting the specific indication
  4. Analyze safety and effectiveness implications of the specific indication
  5. Consider consulting with relevant FDA division before submission
  6. Determine if clinical data will be needed to support the specific indication
  7. Evaluate if a 510(k) is appropriate or if a PMA might be required based on the assessment of all factors
  8. Document justification for why the specific indication falls within the general use scope
  9. Consider impact on public health and risk profile when determining regulatory pathway

Key Considerations

Labelling

  • Changes in indications must be evaluated for their impact on safety and effectiveness
  • Specific indications generally narrow the indication with respect to function, target population, organ/organ system, tissue type, disease entity, or analyte

Safety

  • New specific indications should not introduce new risks not normally associated with the general use
  • Safety impact must be evaluated when changing from general to specific use

Other considerations

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Original guidance

  • General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
  • HTML / PDF
  • Issue date: 1998-11-03
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Pediatric Product Development
  • ReguVirta summary file ID: 89a3b9b7d892ba15a305facd482eb081
This post is licensed under CC BY 4.0 by the author.