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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:.jpg "7(3).jpg")
510(k) Premarket Notification: Typically takes 3 to 6 months from submission to clearance.
Premarket Approval (PMA): Can take 6 months to several years, depending on the complexity and data requirements.
De Novo Classification: Generally takes 6 to 12 months.
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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