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What is the validity period of a U.S. Medical Device Certificate?
Category：企業(yè)動態(tài) Date：2024-12-24 17:09:46 Author: Source:
The validity period of a U.S. Medical Device Certificate is typically tied to the annual registration renewal process rather than a fixed expiration date. Here are key points regarding the validity and renewal process for medical device certificates in the United States:

The validity period of a U.S. Medical Device Certificate is typically tied to the annual registration renewal process rather than a fixed expiration date. Here are key points regarding the validity and renewal process for medical device certificates in the United States:

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1. Device Registration and Listing

  • FDA Device Registration: Manufacturers, including foreign manufacturers, must register their establishment and list their medical devices with the FDA. This registration is renewed annually.
  • The registration and listing must be updated by December 31st of each year to remain active. If not renewed, the device is considered unregistered, and the manufacturer may face regulatory actions, including the inability to market the device in the U.S.

2. Premarket Approval or 510(k) Clearance

  • Premarket Approval (PMA) for Class III devices and 510(k) clearance for most Class II devices do not have a specific expiration date. Once granted, they remain valid unless the device is modified in a way that affects its classification or intended use. However, the FDA may require periodic updates or additional information if new risks or concerns arise about the device.

3. Certification Validity

  • Medical Device Certificates such as those granted under the FDA’s premarket approval (PMA) or 510(k) processes generally remain valid indefinitely, provided the device is manufactured according to the approved specifications and continues to meet regulatory requirements.
  • However, annual registration renewal is required to maintain the validity of the device’s registration. If the registration is not renewed by the end of each year, the device is considered "unregistered," and the manufacturer cannot legally distribute it in the U.S.

4. Post-market Compliance

  • Even after registration and certification, manufacturers are responsible for ensuring ongoing compliance with FDA regulations, including post-market surveillance, adverse event reporting, and compliance with labeling requirements. Non-compliance could lead to the suspension or revocation of approval or certification.

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