The review process for medical device registration with the US FDA typically follows these steps, depending on the device classification (Class I, II, or III) and type of submission (e.g., 510(k), Premarket Approval (PMA)):

1. Device Classification:

   • The first step is to determine the device's classification (Class I, II, or III) based on its intended use and risk level. This classification will determine which regulatory pathway is required for approval.

2. Determine the Type of Submission:

   • 510(k) Premarket Notification: For most Class I and Class II devices (unless exempt), manufacturers must submit a 510(k) to demonstrate that the device is substantially equivalent to a legally marketed device.
   • Premarket Approval (PMA): For Class III devices, manufacturers must submit a PMA application, which involves providing extensive clinical and scientific data to support the device’s safety and effectiveness.
   • Exemption: Some Class I devices or certain Class II devices may be exempt from premarket submission.

3. Pre-Submission (optional):

   • Manufacturers may request a Pre-Submission meeting with the FDA to discuss their device and submission requirements before formally submitting an application.

4. Submission of Application:

   • The manufacturer submits the appropriate application (510(k), PMA, or other) with the necessary documentation, including device descriptions, labeling, clinical data (if required), and manufacturing information.

5. FDA Acceptance Review:

   • The FDA reviews the submission to ensure all required information has been provided. If any deficiencies are found, the FDA may request additional information from the manufacturer.

6. FDA Substantive Review:

   • The FDA evaluates the safety, effectiveness, and regulatory compliance of the device. This may involve reviewing clinical trial data (for PMA), substantial equivalence to a predicate device (for 510(k)), and adherence to regulations such as Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).

7. Advisory Committee (if applicable):

   • For certain high-risk devices (usually Class III), the FDA may convene an advisory committee to review the data and make recommendations about the device's approval.

8. FDA Decision:

   • The FDA issues a decision regarding the application:
     • 510(k): If the device is found to be substantially equivalent to a predicate device, the FDA will issue a clearance letter, allowing the device to be marketed in the U.S.
     • PMA: If the device meets the necessary requirements, the FDA will issue an approval letter. If the device is not approved, the manufacturer may need to submit additional data or redesign the device.

9. Post-Market Requirements:

   • After the device is cleared or approved, the manufacturer must comply with FDA post-market requirements, including adverse event reporting (MDR), recalls (if necessary), and ongoing compliance with Good Manufacturing Practices (GMP).

10. Surveillance and Monitoring:

• The FDA monitors the device’s performance in the market, requiring the manufacturer to report any adverse events and ensuring continued compliance with regulatory standards.

The timeline for the review process can vary:

• 510(k) clearance: Typically takes about 3-6 months.
• PMA approval: Can take 6 months to several years, depending on the complexity and risk of the device.

The FDA's goal is to ensure that medical devices are safe, effective, and manufactured according to stringent quality standards before being sold to the public.

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