Here are the steps for FDA registration of medical devices:

1. Determine Device Classification:

   • Identify whether your device is Class I, II, or III. This will guide the regulatory requirements you must follow.

2. Establish a Facility:

   • Ensure compliance with FDA regulations. If you are a foreign manufacturer, designate a U.S. agent.

3. Prepare Pre-market Submission:

   • Class I Devices: Typically exempt from pre-market notification but still require establishment registration and device listing.
   • Class II Devices: Prepare a 510(k) pre-market notification to demonstrate substantial equivalence to a legally marketed device.
   • Class III Devices: Prepare a PMA (Pre-Market Approval) submission, which includes comprehensive data such as clinical trials.

4. Submit Registration and Listing Forms:

   • Complete and submit FDA Form 2891 for establishment registration.
   • Complete and submit FDA Form 2892 for device listing.

5. Prepare and Submit Pre-market Application:

   • 510(k): Submit the 510(k) notification with relevant documentation.
   • PMA: Submit the PMA application, including detailed clinical data and device information.

6. FDA Review Process:

   • The FDA reviews your submission. For 510(k) submissions, this typically takes around 90 days. PMA reviews can take several months to years.

7. Receive FDA Decision:

   • 510(k): Receive a clearance letter if the device is found substantially equivalent.
   • PMA: Receive an approval letter if the device meets all FDA requirements.

8. Post-Market Compliance:

   • Adhere to FDA regulations for labeling, reporting adverse events, and maintaining records.

Following these steps ensures that your medical device meets FDA requirements and is legally marketed in the United States.

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