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The approximate number of days to obtain FDA certification in the United States varies based on the type of product and regulatory pathway. Here’s a general breakdown:

1. Medical Devices:

   • 510(k) Notification: The review process typically takes about 90 days. However, this can extend if additional information or clarification is needed from the applicant. Total processing time, including preparation and potential follow-ups, may range from 3 to 6 months.
   • Premarket Approval (PMA): Generally, the PMA process takes between 180 and 360 days. This includes the time required for FDA review, which may be extended if the FDA requests additional data or if there are significant questions about the submission. Overall, from submission to approval, the process might take up to a year or more.
   • De Novo Classification: The review period for a De Novo request is usually around 120 days. As with other submissions, this timeframe can be extended depending on the complexity of the device and the completeness of the information provided.

2. Drugs:

   • New Drug Application (NDA): The standard review time is approximately 10 months. For drugs that receive priority review, this can be reduced to about 6 months. The total time from initial submission to approval may be around 6 to 12 months, considering potential interactions with the FDA.
   • Abbreviated New Drug Application (ANDA): The review process for generic drugs typically takes around 10 months. This timeline can vary based on the completeness of the submission and any additional FDA queries.

3. Biologics:

   • Biologics License Application (BLA): The standard review time is about 10 months. If the application qualifies for priority review, this can be reduced to approximately 6 months. The entire process, including preparation and FDA interactions, might span from 6 to 12 months.

4. Food Products:

   • Generally Recognized as Safe (GRAS) Notification: The review period can vary significantly, typically taking several months to a year. This depends on the complexity of the safety data provided and the FDA’s evaluation process.

Overall, while the FDA's review times provide a general guideline, actual processing times can be influenced by the completeness of the submission, the need for additional information, and the FDA's current workload.

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