The FDA certification review process for medical devices in the United States varies based on the classification of the device (Class I, II, or III) and the type of submission (e.g., 510(k), Premarket Approval (PMA)). Below is an outline of the review process for medical devices:

1. Determine Device Classification

• The first step is determining the device classification. The FDA classifies medical devices into three categories based on risk:
  • Class I: Low risk (e.g., bandages, surgical instruments).
  • Class II: Moderate risk (e.g., infusion pumps, diagnostic devices).
  • Class III: High risk (e.g., pacemakers, heart valves).

The classification determines the regulatory requirements and submission process for FDA review.

2. Choose the Appropriate Submission Pathway

Depending on the classification, the appropriate pathway must be selected for FDA review:

• Class I Devices:
  • Most Class I devices are exempt from premarket notification or approval, but manufacturers must still register the device with the FDA and comply with General Controls, including Good Manufacturing Practices (GMP) and labeling requirements.
• Class II Devices:
  • 510(k) Premarket Notification is typically required for Class II devices. Manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device.
  • If the device is substantially equivalent, the FDA will clear the device for marketing.
• Class III Devices:
  • Premarket Approval (PMA) is required for Class III devices, which are subject to a more rigorous review process. This includes submission of clinical data, non-clinical testing data, and manufacturing details.
  • The FDA will conduct a detailed review of the data to determine if the device is safe and effective for its intended use.

3. Prepare and Submit Documentation

• The documentation required depends on the device's classification and the type of submission:
  • For 510(k): The submission must include device description, labeling, performance testing data, and a comparison to a predicate device.
  • For PMA: A more comprehensive package is required, including clinical data, non-clinical testing, risk management documentation, manufacturing information, and labeling.

Submissions are usually made electronically through the FDA’s Electronic Submission Gateway (ESG).

4. FDA Review Process

The FDA’s review process involves several steps, depending on the submission pathway:

• For 510(k) Submissions (Class II Devices):
  1. Initial Screening: The FDA reviews the 510(k) submission for completeness and determines whether the device is substantially equivalent to a predicate device.
  2. Technical Review: A technical review is conducted to evaluate the device’s safety, effectiveness, and labeling.
  3. FDA Decision: If the device is found to be substantially equivalent, the FDA will issue a clearance letter, allowing the device to be marketed in the U.S.
• For PMA Submissions (Class III Devices):
  1. Acceptance Review: The FDA checks if the PMA submission is complete. If it is accepted, the FDA proceeds with a detailed review.
  2. Clinical and Non-Clinical Review: The FDA evaluates clinical trial data, performance testing, risk management information, and other relevant documentation.
  3. Advisory Panel Review: In some cases, an FDA advisory panel of experts may be convened to evaluate the device.
  4. FDA Decision: After a comprehensive review, the FDA may issue an approval letter, permitting the device to be marketed in the U.S. If the device does not meet the required standards, the FDA will issue a refuse to approve (RTA) letter.
• For Class I Devices: Typically, no formal premarket submission is required, but the manufacturer must register the device and adhere to labeling and manufacturing requirements.

5. FDA User Fees

• The FDA charges user fees for 510(k) submissions and PMA applications, which vary depending on the type of submission and the size of the company.
• Fees are paid at the time of submission.

6. FDA Decision

• 510(k) Clearance: For Class II devices, if the FDA determines the device is substantially equivalent to a predicate device, it will issue a 510(k) clearance, allowing the device to be marketed.
• Premarket Approval (PMA): For Class III devices, if the FDA determines the device is safe and effective, it will grant PMA approval.
• De Novo Classification: If the device is novel and does not have a predicate, the manufacturer may request a De Novo classification, which may allow the device to be classified as Class I or II.

7. Post-Market Surveillance

After FDA certification, manufacturers must comply with post-market requirements, including:

• Medical Device Reporting (MDR): Reporting adverse events related to the device.
• Post-market surveillance: Conducting ongoing monitoring of the device’s performance and safety.

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