IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
This guidance outlines FDA's framework for categorizing Investigational Device Exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) in making Medicare coverage decisions. It explains how FDA determines whether an IDE device should be categorized as Category A (Experimental) or Category B (Non-experimental/investigational), which impacts CMS reimbursement decisions.
Recommended Actions
- Evaluate available clinical and non-clinical data to determine if initial safety and effectiveness questions are resolved
- Consider whether the device meets any of the Category A criteria:
- No prior approval/clearance and unresolved initial questions
- New indication with unresolved questions
- Different technological characteristics with unresolved questions
- Consider whether the device meets any of the Category B criteria:
- Available data resolves initial questions
- Information from previous uses resolves questions for new indication
- Similar characteristics to marketed device with resolved questions
- Document justification for category determination based on available data
- Monitor for new data that could support category changes from A to B
- Submit IDE supplements to request category changes when appropriate
- Communicate category changes to CMS when they occur
- Maintain documentation of category determinations and any changes
- Consider staged study approaches that could allow transition from Category A to B
- Review CMS coverage criteria in addition to FDA categorization requirements
Key Considerations
Clinical testing
- Clinical data can be used to resolve initial questions of safety and effectiveness
- Data from feasibility studies, pivotal studies, or studies conducted outside the U.S. can support categorization decisions
- Staged clinical studies may allow category changes from A to B as data is collected
Non-clinical testing
- Non-clinical data can support resolving initial safety and effectiveness questions
- Can be used as supportive information for category changes
- May be sufficient to resolve some questions when combined with existing clinical experience
Safety
- Initial safety questions must be resolved for Category B designation
- Safety data from similar devices can support categorization decisions
- New anatomical locations or uses may raise new safety questions requiring Category A designation
Other considerations
- Category decisions are independent of study type (feasibility vs pivotal)
- Categories can change from A to B when new data resolves initial questions
- Sponsors can request category changes through IDE supplements
- Category changes for one device don’t automatically apply to similar devices
- Novel devices with no previous human use typically start as Category A
- Device modifications may warrant different categories based on the extent of changes
Relevant Guidances
- IDE Clinical Investigation Decision Process and Requirements
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
Related references and norms
- 42 CFR 405.201: Definitions of Category A and Category B devices
- 42 CFR 405.211: Medicare coverage requirements for IDE studies
- 42 CFR 405.212: Medicare coverage IDE study criteria
Original guidance
- IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
- HTML / PDF
- Issue date: 2017-12-05
- Last changed date: 2020-10-20
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Biologics
- ReguVirta summary file ID: 9453c37598015b6ab7d53a251a55125c
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