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What Is the Validity Period for FDA Certification?
Category：行業(yè)資訊 Date：2024-08-26 17:16:24 Author: Source:
In summary, FDA clearances and approvals like 510(k) and PMA are valid indefinitely as long as compliance is maintained, whereas registration requires annual renewal.

The validity period for FDA certification varies depending on the type of product and certification:2.jpg

  1. 510(k) Clearance:

    • Validity: A 510(k) clearance does not have an expiration date but is valid as long as there are no significant changes to the device that would require a new submission.
    • Maintenance: Manufacturers must continue to comply with FDA regulations and may need to update their 510(k) if there are significant changes to the device or its intended use.

  2. Premarket Approval (PMA):

    • Validity: PMA approvals are generally valid indefinitely as long as the device is manufactured and marketed according to the approved specifications and conditions.
    • Renewal: PMA does not require renewal, but manufacturers must adhere to FDA regulations and maintain compliance with post-market requirements.

  3. De Novo Classification:

    • Validity: De Novo classifications are valid indefinitely, similar to PMA approvals, provided the device remains unchanged and the manufacturer adheres to FDA regulations.
    • Post-Market: Manufacturers must comply with ongoing FDA requirements and report any changes or issues with the device.

  4. CE Marking (for comparison):

    • Validity: CE marking is valid as long as the product meets EU regulations, and periodic audits by the Notified Body are required to maintain compliance.
    • Reassessment: Manufacturers need to reassess compliance and undergo periodic evaluations to retain the CE mark.

  5. Device Registration and Listing:

    • Validity: Device registration with the FDA needs to be renewed annually. However, this does not imply re-certification but is necessary to keep the registration active.

In summary, FDA clearances and approvals like 510(k) and PMA are valid indefinitely as long as compliance is maintained, whereas registration requires annual renewal.

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