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GAWP/WG2WG1WG3/F001:2023FINAL DOCUMENT
Title:Categorization of Changes to a Registered
Medical DeviceAuthoring Group:Work Group 1, Premarket: General MD
Work Group 2, Premarket: IVD
Work Group 3,
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Who needs content of premarket submissions?
01
Medical device manufacturers who are seeking approval from regulatory agencies to market their products.
02
Healthcare facilities that are looking to purchase and use medical devices in their practice.
03
Regulatory agencies responsible for evaluating the safety and effectiveness of medical devices.
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What is content of premarket submissions?
Premarket submissions typically include information about the safety and effectiveness of a medical device.
Who is required to file content of premarket submissions?
Manufacturers and importers of medical devices are required to file premarket submissions.
How to fill out content of premarket submissions?
Premarket submissions should be filled out with accurate and detailed information about the medical device.
What is the purpose of content of premarket submissions?
The purpose of premarket submissions is to demonstrate that a medical device is safe and effective for its intended use.
What information must be reported on content of premarket submissions?
Information such as device specifications, performance testing results, manufacturing processes, and labeling must be reported on premarket submissions.
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