For Class I medical devices cleared through the 510(k) process, the FDA generally does not require an annual review of the clearance itself. Once a Class I medical device receives FDA clearance, it remains valid as long as the device continues to meet all applicable regulatory requirements and there are no changes that would affect its substantial equivalence to the predicate device.

However, there are ongoing responsibilities and requirements that manufacturers must fulfill post-clearance to maintain compliance with FDA regulations:

1. Quality System Regulation (QSR): Manufacturers of Class I devices must comply with FDA's Quality System Regulation (QSR) (21 CFR Part 820), which mandates the establishment and maintenance of a quality management system.

2. Labeling and Advertising: Ensure that device labeling, advertising, and promotional materials comply with FDA requirements, including any updates or changes necessary to reflect current information or regulations.

3. Post-Market Surveillance: Manufacturers are responsible for monitoring the performance of their devices in the market and reporting adverse events, complaints, and other safety issues to the FDA as per regulations.

4. Complaint Handling: Implement procedures for handling complaints and maintaining records of complaints, investigations, and corrective actions.

5. Device Tracking (if applicable): Some Class I devices may require device tracking, which involves establishing methods and procedures for tracking the device from production through distribution to the end-user.

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