The estimated time to obtain FDA certification varies depending on the type of product and the specific regulatory pathway:
510(k) Premarket Notification: 3 to 6 months
Premarket Approval (PMA): 6 months to several years depending on complexity
De Novo Classification: 6 to 12 months
Registration and Listing: Days to weeks if no premarket submission is required
These times can vary based on factors such as the completeness of the submission and the FDA’s review process.
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