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The expected timeframe for obtaining FDA registration and certification in the United States varies depending on the product type and regulatory pathway:

1. Medical Devices:

   • 510(k) Notification: Typically takes about 90 days for review. Including preparation and potential follow-ups, the entire process may take 3 to 6 months.
   • Premarket Approval (PMA): Generally ranges from 180 to 360 days. With preparation and possible additional information requests, the process may extend up to a year or more.
   • De Novo Classification: Usually about 120 days for review. Total time may be longer depending on the complexity of the device.

2. Drugs:

   • New Drug Application (NDA): Standard review takes around 10 months, with priority review shortening this to about 6 months. Overall, from submission to approval, it can range from 6 to 12 months.
   • Abbreviated New Drug Application (ANDA): Generally takes around 10 months. This timeframe can vary based on the completeness of the submission and FDA requests.

3. Biologics:

   • Biologics License Application (BLA): Typically takes about 10 months, with priority review reducing this to around 6 months. The total process may span 6 to 12 months, including preparation and communication.

4. Food Products:

   • Generally Recognized as Safe (GRAS) Notification: The review process can take several months to a year, depending on the complexity and data provided.

These timeframes are general estimates and can be influenced by factors such as submission quality, additional information requests, and the FDA’s workload.

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