For FDA certification of medical devices, an annual review or renewal process specifically tied to the certification itself is not typically required. However, there are important ongoing requirements and activities that manufacturers must fulfill to maintain compliance and ensure the continued validity of their FDA certification. Here are the key considerations:

1. Quality System Regulation (QSR) Compliance: Manufacturers of FDA-certified medical devices must comply with the FDA's Quality System Regulation (21 CFR Part 820), which mandates comprehensive quality management practices. This includes maintaining proper documentation, implementing corrective and preventive actions (CAPA), and conducting regular internal audits to ensure ongoing compliance.

2. Post-Market Surveillance: Manufacturers are required to monitor their devices post-market for adverse events, device malfunctions, and other safety issues. Reporting obligations to the FDA include Medical Device Reporting (MDR) for adverse events and corrections or removals of devices from the market (Recalls).

3. Labeling and Promotion Compliance: Device labeling and promotional materials must accurately reflect the FDA-approved or cleared indications for use, warnings, and intended use statements. Any changes to labeling or promotional claims may require FDA review and approval.

4. Annual Establishment Registration and Device Listing: Manufacturers are required to renew their establishment registration annually with the FDA through the Unified Registration and Listing System (FURLS). This registration includes listing all devices manufactured, imported, or distributed in the United States.

5. Premarket Notification (510(k)) Updates: If changes are made to a 510(k)-cleared device that could affect its safety or effectiveness, manufacturers may need to submit a new 510(k) or a Notification of Change (510(k) N) to the FDA for review and clearance.

6. Premarket Approval (PMA) Supplements: For PMA-approved devices, manufacturers must submit PMA supplements to the FDA for significant changes or modifications to the device or its manufacturing process that could affect safety or effectiveness.