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.
What You Need to Know? 👇
What is the 1-CARD pilot program for pacemaker manufacturers?
The 1-CARD (1-Consolidated Annual Report for a Device product line) is an FDA pilot program allowing pacemaker manufacturers to submit one consolidated annual report covering multiple PMA/PDP applications within their entire product line, reducing regulatory burden and duplication.
How many copies of a 1-CARD submission should be sent to FDA?
Manufacturers should submit two copies of each 1-CARD submission to the PMA Document Mail Center (HFZ-401) at FDA’s Center for Devices and Radiological Health, clearly identified as “Annual Report” with all referenced PMA/PDP numbers.
What survival probability data must be included in 1-CARD reports?
Reports must include both graphical and tabular survival probability data grouped by platform and model family. Data should cover registered implants, active implants, failures, and actuarial survival probability at one-year intervals through year ten, then two-year intervals thereafter.
How should reportable changes be documented in 1-CARD submissions?
All changes under 21 CFR 814.39(a) and (b) must be identified. When changes affect multiple PMAs/PDPs, they need only be reported once but must cite each affected platform, family, or model name and applicable supplement numbers.
What information about device failures must be included in 1-CARD reports?
Reports must detail explant reasons, failure modes, and affected components. If failed components exist in other models, those must be identified with analysis of potential impact. Remedial actions for failure patterns must be clearly explained.
What historical information about advisories and recalls should be summarized?
The 1-CARD must summarize all advisories, safety alerts, and recalls throughout the history of covered PMAs/PDPs, describing the problem, cause, clinical consequences, affected devices, and remedial actions taken for proper FDA evaluation.
What You Need to Do 👇
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 đź”—
- 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