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Key Milestones and Timing Points in the FDA Certification Process in the U.S.?
Category：行業(yè)資訊 Date：2024-09-18 17:28:34 Author: Source:
Overall, the entire FDA certification process can range from a few months to several years, depending on the device type, submission pathway, and complexity.

The FDA certification process in the U.S. involves several key milestones and timing points that are crucial for obtaining approval for a medical device. Here's a brief overview:7(4).jpg

  1. Pre-Submission: Before formally submitting your application, it's beneficial to engage in pre-submission meetings with the FDA. This allows you to discuss your device, get feedback on your proposed studies, and understand FDA expectations. Timing for this step varies but typically occurs several months before the formal submission.

  2. Submission of Application: The formal submission includes a 510(k) premarket notification, PMA (Premarket Approval), or De Novo request, depending on the device classification. The timing for this step depends on the type of submission. For example, a 510(k) submission might be prepared over several months.

  3. Acceptance Review: After submission, the FDA conducts an acceptance review to ensure that the application is complete and that all required information is included. This step usually takes around 15 days.

  4. Substantive Review: The FDA then performs a detailed review of the submitted data. For 510(k) submissions, this review typically takes about 90 days. For PMA applications, the review process is more extensive and can take up to 180 days or longer, depending on the complexity.

  5. Pre-Market Inspection: If required, the FDA will conduct an inspection of the manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP). This inspection usually occurs during the substantive review phase.

  6. FDA Decision: After completing the review and inspection, the FDA will issue a decision. For 510(k) submissions, a decision is generally made within 90 days. For PMAs, it may take up to 180 days or more.

  7. Post-Market Requirements: After receiving FDA clearance or approval, you must adhere to post-market requirements, including adverse event reporting and periodic reviews.

Overall, the entire FDA certification process can range from a few months to several years, depending on the device type, submission pathway, and complexity.

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