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Is Clinical Testing Required for FDA Certification of Medical Devices?
Category：行业资讯 Date：2024-09-14 16:35:28 Author: Source:
Ultimately, whether clinical testing is needed depends on the specific device and the regulatory pathway chosen.

Clinical testing is not always required for FDA certification of medical devices; it depends on the type of device and its intended use:2.jpg

  1. 510(k) Submission: Clinical testing is not always required for devices that are considered substantially equivalent to a legally marketed device. However, if the new device raises new questions of safety or effectiveness, clinical data may be needed.

  2. Premarket Approval (PMA): Clinical testing is generally required for PMA submissions. The FDA requires robust clinical data to demonstrate the safety and effectiveness of high-risk devices.

  3. De Novo Request: Clinical data may be required for De Novo submissions, particularly if the device is novel and does not have a predicate device for comparison.

Ultimately, whether clinical testing is needed depends on the specific device and the regulatory pathway chosen.

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