For Class II medical devices, FDA clearance (510(k) clearance) does not typically require annual renewal like some other certifications or registrations. Once a device receives FDA clearance, it remains valid indefinitely for marketing in the United States, assuming there are no changes to the device that would require a new submission or notification to the FDA.

However, there are ongoing obligations and considerations for manufacturers post-clearance:

1. Quality System Regulation (QSR) Compliance: Manufacturers must comply with FDA's Quality System Regulation (21 CFR Part 820), which mandates establishment and maintenance of quality systems to ensure device safety and effectiveness.

2. Post-Market Surveillance: Manufacturers are required to monitor and report adverse events related to their devices as part of post-market surveillance obligations. This helps ensure ongoing safety and effectiveness of the marketed devices.

3. Labeling Updates: Manufacturers must update device labeling as necessary to reflect any changes in indications for use, warnings, precautions, or other relevant information.

4. PMA Supplements or New 510(k) Submissions: If significant changes are made to the device that could affect its safety or effectiveness, manufacturers may need to submit a new 510(k) or Premarket Approval (PMA) supplement to the FDA.

5. Inspections and Compliance: The FDA may conduct inspections of manufacturing facilities to ensure compliance with regulatory requirements and quality standards.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn