FDA certification for medical devices generally does not have an "expiration date" in the traditional sense, but there are several ongoing requirements and processes to maintain compliance:

1. Registration and Listing:

   Medical device manufacturers must renew their registration and device listing with the FDA annually. The registration fee is approximately $5,000 per year.

2. Premarket Approvals (PMA) and 510(k) Submissions:

   510(k) Clearances: Once granted, a 510(k) clearance remains valid as long as the device continues to meet the conditions specified and the device does not undergo significant changes that would require a new 510(k).PMA Approvals: PMA approvals are generally valid as long as the device remains compliant with FDA regulations. Significant changes to the device or manufacturing processes may require a new PMA submission.

3. Quality System Regulation (QSR):

   Manufacturers must comply with the FDA’s Quality System Regulation (QSR), which requires ongoing adherence to good manufacturing practices.The FDA may inspect facilities periodically to ensure compliance.

4. Post-Market Requirements:

   Devices must adhere to post-market surveillance requirements, including reporting adverse events and maintaining records. Failure to comply with these requirements can impact the device's market status.

5. Renewal Process:

   For continuing FDA certification, manufacturers need to stay updated with any new regulations, complete annual registration renewals, and ensure compliance with FDA standards. If significant changes occur, new submissions or amendments might be required.

Maintaining FDA certification involves continuous compliance with regulatory requirements rather than a straightforward renewal process.

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