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What Are the Key Stages in the FDA Certification Application Timeline?
Category：行業(yè)資訊 Date：2024-09-20 16:56:33 Author: Source:
Each stage's duration can vary depending on the product type and specific circumstances.

The key stages in the FDA certification application timeline typically include:7(2).jpg

  1. Pre-Submission Activities: This involves preparing necessary documents and data, conducting preclinical studies, and engaging in discussions with the FDA if needed.

  2. Submission of Application: This is when the formal application, such as a 510(k) or PMA, is submitted to the FDA.

  3. FDA Review: The FDA reviews the application, which may involve additional information requests and may take several months.

  4. Inspection: If applicable, the FDA may conduct an inspection of the manufacturing facility to ensure compliance with regulations.

  5. Decision: The FDA issues a decision on the application, either granting approval or requiring further action.

  6. Post-Market Surveillance: After approval, ongoing monitoring and reporting of product performance are required.

Each stage's duration can vary depending on the product type and specific circumstances.

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