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The registration cycle for Class II medical devices in the United States?
Category：行業(yè)資訊 Date：2024-08-01 17:31:07 Author: Source:
The registration cycle for Class II medical devices in the United States typically involves several key stages and can vary in duration based on factors such as completeness of submission and FDA review timelines. Generally, the process begins with preparation and submission of a 510(k) premarket notification, which includes device information, intended use, and substantial equivalence to a predicate device. FDA's initial review determines if the submission is administratively complete, after which a substantive review follows to assess safety and effectiveness. This phase includes communication with FDA, potentially involving requests for additional information (AI) or additional documentation (AD). The timeline may be influenced by the volume of submissions and the complexity of the device, with some submissions being expedited through programs like the Special 510(k) or the Abbreviated 510(k).

The registration cycle for Class II medical devices in the United States typically involves several key stages and can vary in duration based on factors such as completeness of submission and FDA review timelines. Generally, the process begins with preparation and submission of a 510(k) premarket notification, which includes1(7).jpg device information, intended use, and substantial equivalence to a predicate device. FDA's initial review determines if the submission is administratively complete, after which a substantive review follows to assess safety and effectiveness. This phase includes communication with FDA, potentially involving requests for additional information (AI) or additional documentation (AD). The timeline may be influenced by the volume of submissions and the complexity of the device, with some submissions being expedited through programs like the Special 510(k) or the Abbreviated 510(k).

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