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The typical review timeline for FDA registration of medical devices varies based on the device's classification and the type of submission:

1. Class I Devices:

   • Generally exempt from pre-market notification but must comply with general controls. No specific review timeline as they are usually not subject to a pre-market review.

2. Class II Devices:

   • 510(k) Submission: The FDA typically reviews 510(k) submissions within 90 days. This timeline can vary based on the completeness of the submission and the need for additional information or testing.

3. Class III Devices:

   • Pre-Market Approval (PMA): The review process for PMA submissions is more extensive and can take several months to several years. The FDA aims to review PMA applications within 180 days, but this can extend if additional data or revisions are required. The complexity of the device and the amount of clinical data involved play significant roles in the review duration.

In both cases, delays can occur due to incomplete submissions, requests for additional information, or issues identified during the review process. Manufacturers can expedite their applications through various programs like the FDA’s Breakthrough Devices Program, which aims to speed up the review process for devices that provide significant benefits over existing options.

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