The typical processing time for FDA registration and certification in the USA varies depending on the type of product and regulatory pathway. Here’s a general breakdown:
FDA Device Registration and Listing:
510(k) Premarket Notification:
Premarket Approval (PMA):
De Novo Classification:
Investigational Device Exemption (IDE):
These times are approximate and can vary based on the submission's quality, completeness, and FDA workload. For precise timelines, consulting with the FDA or a regulatory expert is advised.
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