Obtaining FDA certification for medical devices in the United States involves several steps:

1. Classification of Your Device: Determine the appropriate classification of your device under the FDA's classification system (Class I, II, or III). This classification will dictate the regulatory pathway and requirements.

2. Premarket Notification (510(k)) or Premarket Approval (PMA):

   • Class I Devices: Generally exempt from Premarket Notification (510(k)) unless they are intended for a use that is not substantially equivalent to a legally marketed device.
   • Class II Devices: Typically require a 510(k) submission, demonstrating that the device is substantially equivalent to another legally marketed device (predicate).
   • Class III Devices: Require a Premarket Approval (PMA) application, which includes extensive scientific data to demonstrate the device's safety and effectiveness.

3. Prepare and Submit Application:

   • 510(k) Submission: Includes a detailed comparison to the predicate device, testing data, labeling, and other relevant information.
   • PMA Application: Requires clinical data, laboratory studies, manufacturing information, and more comprehensive evidence of safety and effectiveness.

4. FDA Review Process: The FDA will review the submission or application to ensure compliance with regulatory requirements. This may involve requests for additional information or clarification.

5. Inspection: For some devices, the FDA may conduct an inspection of the manufacturing facilities to ensure they comply with Quality System (QS) regulations.

6. Decision: Upon successful review and acceptance of the application, the FDA will issue an approval or clearance letter. This allows the device to be legally marketed in the United States.

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