Consolidated Annual Reporting for Pacemaker Product Lines (1-CARD)
This guidance outlines an alternative method called 1-CARD for submitting consolidated annual reports for pacemaker product lines, covering multiple PMA or PDP applications in a single report. Initially piloted for cardiac pacemakers, this approach aims to streamline reporting requirements and improve efficiency in identifying device-related issues across product lines.
Recommended Actions
- Establish a system to track and consolidate data across the entire pacemaker product line
- Develop a standardized format for survival probability reporting
- Create a “family tree” mapping of products showing platform and model relationships
- Implement a tracking system for all reportable changes affecting multiple PMAs
- Set up a process for analyzing and reporting deaths, explants, and returns
- Maintain comprehensive records of all advisories, safety alerts, and recalls
- Create a system for monitoring and reporting programmer performance
- Establish a process for maintaining and updating the bibliography of relevant literature
- Develop templates for consistent reporting across all required sections
- Set up a review process to ensure all affected models are properly identified when reporting issues
Key Considerations
Clinical testing
- Deaths must be reported and categorized as pacemaker-related or non-pacemaker related
- Clinical data from unpublished reports must be included in the bibliography
Non-clinical testing
- Non-clinical laboratory studies data must be included in the bibliography if not previously submitted
Software
- Software module failures must be reported and analyzed for impact across different models
Safety
- All advisories, safety alerts, and recalls must be summarized
- Problem description, affected devices, and remedial actions must be detailed
- Patient management recommendations must be included for safety-related issues
Other considerations
- Two copies of the 1-CARD submission required
- Cover letter must include all referenced PMAs and PDPs
- Pacemaker survival probability must be reported graphically and in tabular format
- Changes under 21 CFR 814.39(a) and (b) must be identified
- Explant analysis required with detailed breakdown of causes
- Programmer shipments and returns must be reported
- Bibliography of scientific literature must be maintained
Relevant Guidances
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Content of Premarket Submissions for Device Software Functions
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
Original guidance
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