To apply for medical device certification in the United States, you need to follow the process set by the Food and Drug Administration (FDA). Here are the key steps:
Determine the Classification: The FDA classifies medical devices into three categories based on the risk level:
Understand Regulatory Pathways: Depending on the classification, the pathway to approval will differ:
Prepare Required Documentation:
FDA Review:
Post-Market Requirements:
Device Labeling:
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