Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements

What You Need to Know? 👇

What information must be included in a PMA annual report?

Annual reports must identify changes made during the reporting period, provide summaries of unpublished clinical/nonclinical studies, include scientific literature bibliographies, and report device shipment/sales data. Manufacturing, design, and labeling changes require detailed rationales and safety impact assessments.

How long does FDA take to review PMA annual reports?

FDA typically reviews most annual reports within 90 days of receipt. The review assesses reported modifications, documentation adequacy, and determines if changes were appropriately categorized or should have required PMA supplements or 30-day notices instead.

When should device changes be reported in annual reports versus PMA supplements?

Changes that don’t impact safety or effectiveness can be reported annually. However, significant modifications affecting device design, performance, or safety profile require PMA supplements or 30-day notices. The applicant determines appropriate submission type based on impact assessment.

What happens if FDA finds changes were inappropriately reported in annual reports?

If FDA determines reported changes required PMA supplements or 30-day notices, they notify the applicant by letter or email requesting proper submission within a specified timeframe. Office of Compliance review may be necessary for additional regulatory actions.

Are post-approval study reports submitted with annual reports?

No, post-approval study reports must be submitted separately from annual reports, even when due simultaneously. Annual reports should identify the submission date of post-approval study reports to facilitate FDA’s review process for different purposes.

What format requirements apply to PMA annual reports?

Annual reports must be submitted in acceptable eCopy format with a single paper copy of the signed cover letter. The cover letter should include PMA number, device name, company name, report date, and reporting period dates.

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What You Need to Do 👇

Recommended Actions

1. Establish a process to track and document all device changes throughout the year
2. Create separate tracking systems for:
   • Manufacturing changes
   • Design changes
   • Labeling changes
3. Implement a system to monitor and collect:
   • Scientific literature
   • Clinical/non-clinical studies
   • Adverse events
   • Customer complaints
   • Device shipment/implant data
4. Develop templates for:
   • Cover letter
   • Change tables
   • Literature summaries
5. 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
6. Create calendar to ensure timely submission of annual reports
7. Maintain documentation of rationale for changes and determination of reporting category
8. 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

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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

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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 ID: f5f4b65dfaf251566d288290892cf01d