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What does "U.S. Medical Device Certificate Holder" refer to?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-24 17:08:48 Author: Source:
In the context of U.S. medical device regulations, a "U.S. Medical Device Certificate Holder" generally refers to the entity or individual that holds the official approval or registration for a medical device with the U.S. Food and Drug Administration (FDA). This term can apply to various types of certifications, including device registrations or clearances, and reflects the holder's responsibility for ensuring compliance with FDA regulations.

In the context of U.S. medical device regulations, a "U.S. Medical Device Certificate Holder" generally refers to the entity or individual that holds the official approval or registration for a medical device with the U.S. Food and Drug Administration (FDA). This term can apply to various types of certifications, including device registrations or clearances, and reflects the holder's responsibility for ensuring compliance with FDA regulations.

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Key points about the "Certificate Holder" include:

  1. FDA Registration: The certificate holder is the entity responsible for registering the medical device with the FDA, which includes providing detailed information about the device, the manufacturer, and the intended use.

  2. Premarket Approval or Clearance: In some cases, the certificate holder may also be the entity that has obtained premarket approval (PMA) or premarket notification (510(k)) for the device. This involves ensuring that the device is safe and effective before it is marketed in the U.S.

  3. Labeling and Compliance: The certificate holder ensures that the device meets all applicable labeling requirements and adheres to Good Manufacturing Practices (GMP) under FDA's Quality System Regulation (QSR).

  4. Responsibility for Post-Market Surveillance: The certificate holder is responsible for ensuring ongoing compliance after the device is marketed, including reporting adverse events, conducting recalls, and submitting required post-market reports to the FDA.

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