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What is FDA medical device certification?
Category：企業(yè)動態(tài) Date：2024-12-25 17:23:50 Author: Source:
FDA medical device certification refers to the process by which the U.S. Food and Drug Administration (FDA) evaluates and approves medical devices for use in the United States. The certification ensures that medical devices meet the required safety, effectiveness, and quality standards set by the FDA before they can be marketed and sold.

FDA medical device certification refers to the process by which the U.S. Food and Drug Administration (FDA) evaluates and approves medical devices for use in the United States. The certification ensures that medical devices meet the required safety, effectiveness, and quality standards set by the FDA before they can be marketed and sold.

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This process involves the following:

  1. Classification: Devices are classified into one of three categories (Class I, Class II, or Class III) based on their risk level, which determines the level of regulatory control required.

  2. Premarket Notification or Approval: Depending on the device classification, the manufacturer must submit a 510(k) premarket notification for Class II devices, or apply for Premarket Approval (PMA) for high-risk Class III devices.

  3. Compliance with FDA Regulations: Devices must comply with specific regulatory standards, including labeling requirements, manufacturing practices, and post-market surveillance.

  4. Post-Market Requirements: After approval, the FDA continues to monitor the device’s performance and safety, including adverse event reporting and inspections.

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