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The validity period of an FDA certificate depends on the type of certification or approval. Here are some key points:

1. FDA 510(k) Clearance:

   • FDA 510(k) clearance for medical devices does not have an expiration date. However, manufacturers are required to notify the FDA of any significant changes to the device that might affect its safety or effectiveness, which could require a new 510(k) submission.
   • Additionally, the FDA may review the device during inspections to ensure compliance.

2. Premarket Approval (PMA):

   • Like 510(k) clearance, Premarket Approval (PMA) does not have an expiration date once approved. However, the manufacturer must comply with post-approval requirements, including clinical studies and ongoing monitoring.

3. FDA Registration:

   • FDA facility registration, which is required for all manufacturers, typically does not expire, but it needs to be renewed annually. Manufacturers must update their registration if there are significant changes to the facility or its operations.

4. FDA Listing:

   • FDA product listing (for medical devices, drugs, or dietary supplements) also needs to be updated annually. If a manufacturer does not renew their listing or registration, the FDA may remove the products from the market.

5. Certificates for Export:

   • If you're obtaining an FDA certificate for export (such as a Certificate to Foreign Governments or CFSAN certificates), these certificates are generally valid for one year from the date of issuance.

While FDA approvals themselves may not have an expiration date, it is essential to comply with all ongoing regulatory requirements, such as annual renewals, notifications of changes, and inspections, to maintain valid certification.

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