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The typical processing time for FDA registration and certification in the USA varies depending on the type of product and regulatory pathway. Here’s a general breakdown:

1. FDA Device Registration and Listing:

   • Timeframe: Usually a few days to a couple of weeks.

2. 510(k) Premarket Notification:

   • Standard Review: About 90 days, though it can be extended if additional information is needed.

3. Premarket Approval (PMA):

   • Standard Review: Around 180 days. This can extend if additional data is required or if complex issues arise.
   • Priority Review: Typically about 150 days for qualifying devices.

4. De Novo Classification:

   • Standard Review: Generally about 150 days, but it may take longer if more information is needed.

5. Investigational Device Exemption (IDE):

   • Standard Review: Typically around 30 days, varying with study complexity and additional requirements.

These times are approximate and can vary based on the submission's quality, completeness, and FDA workload. For precise timelines, consulting with the FDA or a regulatory expert is advised.

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