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).
What You Need to Know? 👇
What is the difference between general and specific intended use for medical devices?
A general intended use describes broad functionality (e.g., “cut tissue”), while a specific intended use narrows the scope to particular populations, diseases, or outcomes (e.g., “treatment of prostate cancer”). The change typically involves increased specificity regarding function, target population, organ system, or disease entity.
When does adding a specific indication require a PMA instead of 510(k) clearance?
A PMA is typically required when the specific indication introduces new risks, significantly impacts public health, lacks supporting evidence, involves disease-specific treatment, or requires different clinical endpoints than the general use. The FDA evaluates seven key criteria including risk, public health impact, and knowledge base.
What are the levels of specificity for diagnostic medical devices?
The four levels are: (1) identification of physical/biochemical parameters, (2) specific target population or anatomical location, (3) clinical use identification (diagnosis/screening), and (4) clinical outcome effects. Higher specificity levels generally require more scrutiny for substantial equivalence determinations.
Can a device with general labeling be used for specific indications without regulatory submission?
This guidance doesn’t directly address off-label use. However, manufacturers seeking to add specific indications to their labeling must submit appropriate regulatory documentation. The FDA has separate guidance on when modifications require new 510(k) submissions versus when they don’t.
What factors make a specific indication likely to be substantially equivalent to general use?
Specific indications typically qualify as substantially equivalent when they specify sub-specialties with similar procedures, anatomical sites without disease implications, narrow target populations within broader groups, or uses with considerable supporting clinical knowledge and experience in the medical community.
How does the FDA evaluate risk when comparing general versus specific intended use?
The FDA assesses whether specific use introduces new risks not associated with general use, considering factors like target population changes, clinical endpoints, device modifications, need for adjunctive therapy, and whether the device serves as a tool versus being the actual treatment.
What You Need to Do 👇
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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