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What is the processing timeline for FDA registration and certification?
Category：行業(yè)資訊 Date：2024-08-27 16:43:23 Author: Source:
These timelines can vary based on device complexity, application completeness, and FDA review processes.

The processing timeline for FDA registration and certification depends on the type of medical device and the specific regulatory pathway required. Here's a general overview:7(3).jpg

  1. 510(k) Premarket Notification: Typically takes 3 to 6 months from submission to clearance.

  2. Premarket Approval (PMA): Can take 6 months to several years, depending on the complexity and data requirements.

  3. De Novo Classification: Generally takes 6 to 12 months.

  4. Registration and Listing: If no premarket submission is required, it can be completed in days to weeks.

These timelines can vary based on device complexity, application completeness, and FDA review processes.

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