Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
This guidance clarifies requirements for Class III medical device PMA supplements, focusing on three main areas: 1. Use of published literature as supporting evidence 2. Recognition of previously submitted data to avoid duplication 3. Priority review eligibility criteria
Recommended Actions
- When using published literature:
- Ensure sufficient device design/performance details are available
- Verify comparability between published device and supplement device
- Obtain underlying data when possible
- Document multiple independent studies with consistent findings
- For data requirements:
- Review existing PMA/PDP/HDE data for relevance
- Only submit new data necessary to support the change
- Justify use of previously submitted data
- For priority review:
- Determine if the supplement provides significant public health benefits
- Follow updated CDRH policy for expedited review requirements
- Maintain detailed documentation of:
- Clinical protocols and amendments
- Statistical analysis plans
- Complete patient accounting
- Adverse event information
Key Considerations
Clinical testing
- Clinical data detail level should match 21 CFR 814.20(b)(6)(2) requirements including:
- Number of investigators and subjects
- Selection/exclusion criteria
- Safety and effectiveness data
- Adverse reactions and complications
- Patient discontinuation and complaints
- Device failures and replacements
- Statistical analyses
Safety
- Complete safety information must be provided for all patients who died or discontinued
- Adverse events from literature should be considered alongside original PMA/PDP/HDE adverse events
- New indications may require additional safety assessment if presenting new risks
Other considerations
- Published literature can be used as sole basis for approval if:
- Multiple studies by different investigators with consistent findings
- High level of detail in statistical plans and methods
- Objective endpoints
- A priori statistical analysis plans
- Studies conducted by recognized competent investigators
- Previously submitted data can be incorporated without resubmission if relevant
- Additional data requests limited to what’s needed to support the change
Relevant Guidances
- Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Quality System Information Requirements for Premarket Submissions
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
Related references and norms
- 21 CFR 814.20: PMA requirements
- 21 CFR 860.7: Valid scientific evidence requirements
- 21 CFR 814.39: PMA supplement requirements
Original guidance
- Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
- HTML
- Issue date: 1998-05-19
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 1d6f00c9aac4f855fd693766c251af89
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