FDA registration for medical devices is a process where manufacturers submit information to the U.S. Food and Drug Administration (FDA) to comply with regulatory requirements before marketing their devices in the United States. The process involves several key steps:

1. Device Classification: Determine the classification of the device, which affects the regulatory requirements. Devices are classified into Class I, II, or III based on risk and intended use.

2. Device Listing: Manufacturers must list their device with the FDA, providing details about the device and the manufacturer's information.

3. Pre-market Submission: Depending on the classification, different pre-market submissions may be required:

   • 510(k) Premarket Notification: For most Class II devices, demonstrating that the device is substantially equivalent to a legally marketed device.
   • Premarket Approval (PMA): For Class III devices, requiring more rigorous clinical evidence and a detailed review process.
   • De Novo Classification: For devices that are novel and do not have a predicate device.

4. Quality System Regulations (QSR): Manufacturers must comply with FDA's QSR, which outlines requirements for manufacturing processes, quality control, and documentation.

5. Post-market Requirements: After approval, devices are subject to ongoing requirements such as reporting adverse events, maintaining quality systems, and complying with FDA inspections.

FDA registration ensures that medical devices meet safety and effectiveness standards before being marketed in the U.S., helping protect public health.

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