The key stages in the FDA certification application timeline typically include:
Pre-Submission Activities: This involves preparing necessary documents and data, conducting preclinical studies, and engaging in discussions with the FDA if needed.
Submission of Application: This is when the formal application, such as a 510(k) or PMA, is submitted to the FDA.
FDA Review: The FDA reviews the application, which may involve additional information requests and may take several months.
Inspection: If applicable, the FDA may conduct an inspection of the manufacturing facility to ensure compliance with regulations.
Decision: The FDA issues a decision on the application, either granting approval or requiring further action.
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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