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).
Recommended Actions
- Evaluate if the specific indication falls within accepted parameters of general use as defined by the clinical community
- Assess whether the specific indication:
- Involves diagnosis/therapy of particular disease entities
- Presumes specific clinical outcomes
- Provides new diagnostic/therapeutic options impacting patient management
- Review available evidence and knowledge base supporting the specific indication
- Analyze safety and effectiveness implications of the specific indication
- Consider consulting with relevant FDA division before submission
- Determine if clinical data will be needed to support the specific indication
- Evaluate if a 510(k) is appropriate or if a PMA might be required based on the assessment of all factors
- Document justification for why the specific indication falls within the general use scope
- 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
- Public health impact must be assessed for specific indications
- Knowledge base and evidence must support that specific use is a subset of general use
- Clinical endpoints used for general use must be applicable to specific use
- Device’s role as a tool versus treatment must be considered
- Need for adjunctive therapy must be evaluated
- Impact of design changes on general use capabilities must be assessed
Relevant Guidances
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Benefit-Risk Determinations for Medical Device Premarket Review
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
Related references and norms
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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
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