Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
This guidance addresses FDA's expectations concerning annual and periodic reports for PMA-approved devices. It outlines the required content and format of annual reports that PMA holders must submit to FDA, typically one year from the original PMA approval date and annually thereafter. The guidance also briefly touches on Post-Approval Study reports but does not describe them in detail.
Recommended Actions
- Establish a process to track and document all device changes throughout the year
- Create separate tracking systems for:
- Manufacturing changes
- Design changes
- Labeling changes
- Implement a system to monitor and collect:
- Scientific literature
- Clinical/non-clinical studies
- Adverse events
- Customer complaints
- Device shipment/implant data
- Develop templates for:
- Cover letter
- Change tables
- Literature summaries
- Establish review process to:
- Assess impact of changes on safety and effectiveness
- Determine appropriate reporting category (annual report vs PMA supplement)
- Evaluate literature for potential safety/effectiveness impacts
- Create calendar to ensure timely submission of annual reports
- Maintain documentation of rationale for changes and determination of reporting category
- Submit annual report and post-approval study reports separately, even if due at same time
Key Considerations
Clinical testing
- Must provide summary and bibliography of unpublished reports from clinical investigations
- Must provide summary of relevant scientific literature concerning the device
- Should discuss how results/conclusions could impact known safety and effectiveness profile
Non-clinical testing
- Must provide summary and bibliography of unpublished reports from nonclinical laboratory studies
- Should include assessment of potential impact on device safety and effectiveness
Labelling
- Must report labeling changes in a separate table
- Should describe comparison to previously approved version
- Should provide rationale for changes made
Safety
- Must report adverse events that led to device changes
- Should provide MDR numbers if applicable
- Must report any recalls or corrective actions
- Should include any FDA Safety Alerts or Public Health Notifications
Other considerations
- Must provide data about number of devices shipped/sold during reporting period
- For implants, should provide number of devices implanted if available
- Must submit report in acceptable eCopy format with signed paper cover letter
- Should organize changes in separate tables for manufacturing, design, and labeling changes
- Should identify linked/associated changes
- Should provide rationale for determining changes did not impact safety and effectiveness
Relevant Guidances
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Quality System Information Requirements for Premarket Submissions
Original guidance
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- HTML / PDF
- Issue date: 2019-12-16
- Last changed date: 2020-10-20
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket Approval (PMA), Device & Drug Safety, Premarket, Administrative / Procedural
- ReguVirta summary file ID: f5f4b65dfaf251566d288290892cf01d
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