The time required to complete FDA registration and certification varies depending on the type of device and submission. Here’s a general overview:

1. Device Classification and Registration

• Registration: For Class I devices, registration and listing with the FDA typically take a few weeks. This process involves submitting information about the establishment and devices to the FDA's Unified Registration and Listing System (FURLS).

2. 510(k) Notification

• Preparation Time: Preparing a 510(k) can take several months, depending on the complexity of the device and the data required.
• FDA Review Time: The FDA aims to review 510(k) submissions within 90 days of receipt. However, if additional information is requested or if there are significant issues, the process may be extended.

3. Premarket Approval (PMA)

• Preparation Time: Preparing a PMA application, which includes extensive clinical data and detailed documentation, can take a year or more.
• FDA Review Time: The FDA’s goal is to review PMA applications within 180 days, but the review process can be longer, often extending to 1-2 years, depending on the complexity of the device and the need for additional information.

4. De Novo Classification

• Preparation Time: Preparing a De Novo request, which involves establishing a new regulatory category for novel devices, can take several months.
• FDA Review Time: The FDA aims to review De Novo requests within 120 days. Similar to other submissions, review times can vary based on the complexity and additional data required.

5. Breakdown of Total Time

• Class I Devices: Generally, the process is faster as they often do not require premarket notification. The main time is spent on registration and listing.
• Class II Devices: For a 510(k) submission, the total time can range from several months to over a year, including preparation and review.
• Class III Devices: The process is longer due to the need for extensive clinical data and regulatory review, often taking 1-2 years.
• De Novo Classification: The total time can vary but generally falls within the range of several months to a year.

6. Factors Affecting Timeline

• Submission Quality: Well-prepared and complete submissions can expedite the review process.
• FDA Requests: Requests for additional information or clarification can extend the review period.
• Complexity: More complex devices or new technologies may require additional time for review and evaluation.

7. Ongoing Compliance

• Once certified, ongoing compliance with FDA regulations, including postmarket surveillance and reporting, is essential for maintaining certification.

Understanding these timelines can help in planning and managing the FDA certification process more effectively.

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