To obtain FDA certification in the United States, manufacturers must follow a structured process that depends on the type of medical device and its classification (Class I, II, or III). Below is an overview of the general steps involved:

1. Determine the Device Classification:

The first step is to determine the device classification (Class I, II, or III), which will dictate the required regulatory pathway.

• Class I: Low-risk devices, generally exempt from premarket notification but must comply with general controls (e.g., labeling, record-keeping).
• Class II: Moderate-risk devices, requiring a 510(k) Premarket Notification to demonstrate that the device is substantially equivalent to a legally marketed device.
• Class III: High-risk devices, requiring Premarket Approval (PMA), which involves more extensive clinical data and evidence of safety and effectiveness.

2. Premarket Submission (510(k) or PMA):

• 510(k) Notification: For Class II (and some Class I) devices, submit a 510(k) premarket notification. This requires demonstrating that the device is substantially equivalent to an existing legally marketed device. The submission should include device descriptions, labeling, performance data, and test results.
• Premarket Approval (PMA): For Class III devices, submit a PMA application. This involves submitting extensive clinical and non-clinical data, including scientific evidence and possibly clinical trials, to prove that the device is safe and effective.

3. Quality System Regulations (QSR) Compliance:

Manufacturers must comply with the FDA's Good Manufacturing Practice (GMP) regulations, also known as Quality System Regulations (QSR). This involves ensuring the device is produced in a controlled environment that follows rigorous standards for design, manufacturing, and testing processes.

Key requirements include:

• Design controls
• Production and process controls
• Corrective and preventive actions (CAPA)
• Record-keeping and documentation

4. Device Labeling:

Ensure the device labeling complies with FDA standards. This includes accurate descriptions, intended use, instructions for use, warnings, and any other information needed for safe and effective use.

5. Submit to the FDA:

Submit the 510(k) or PMA application to the FDA. The submission should include all required documentation and supporting evidence (e.g., test results, clinical data, risk analyses). The FDA may require additional information if they have concerns or need clarification.

6. FDA Review:

The FDA reviews the submitted application to evaluate whether the device meets the required standards. The review process includes:

• For 510(k): The FDA typically reviews the application within 90 days to determine if the device is substantially equivalent to an already marketed device.
• For PMA: The FDA conducts a more detailed review, which can take 1-2 years, depending on the complexity of the device and the clinical data involved.

7. FDA Inspection:

The FDA may conduct an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP) and the regulatory requirements.

8. Approval or Clearance:

• 510(k) Clearance: If the FDA determines the device is substantially equivalent to a legally marketed device, the device will be cleared for sale.
• PMA Approval: If the FDA concludes that the device is safe and effective based on the submitted data, the device will be approved for sale.

9. Post-Market Surveillance:

After FDA clearance or approval, manufacturers are required to monitor the device’s performance in the market and report any adverse events or device-related issues. This is part of post-market surveillance.

10. FDA Fees:

The FDA charges fees for device registration, 510(k) submissions, PMA applications, and other services. These fees vary depending on the type and complexity of the device.

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