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The typical review cycle duration for FDA certification applications varies depending on the type of product and the specific application. Here is an overview:

1. Medical Devices:

   510(k) Premarket Notification: The review typically takes around 90 days from the submission date. However, the timeline can be extended if the FDA requests additional information.Premarket Approval (PMA): The review process for a PMA application usually takes about 180 days. This can be longer if the FDA requires additional data or an advisory committee meeting.

2. Drugs:

   New Drug Application (NDA): The FDA aims to complete the review within 10 months from the filing date. This can vary depending on the complexity of the drug and the need for additional information.Abbreviated New Drug Application (ANDA): For generic drugs, the review generally takes about 10 months as well.

3. Food and Dietary Supplements:

   Food Facility Registration: Facility registrations are processed relatively quickly, often within a few weeks.Dietary Supplements: If a new dietary ingredient is involved, the FDA may take up to 75 days to review a New Dietary Ingredient (NDI) notification.

4. Biologics:

   Biologics License Application (BLA): The review period typically lasts about 10 months, although this can be extended if additional information or clarification is needed.

In all cases, the review timeline can be influenced by the complexity of the submission, the completeness of the application, and the need for further data or clarification. Engaging with the FDA early in the process through pre-submission meetings can help streamline the review and potentially reduce delays.

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