The process for medical device certification in the United States involves several steps, primarily regulated by the U.S. Food and Drug Administration (FDA). The process depends on the classification of the device, which can fall into one of three classes (Class I, II, or III) based on the level of risk associated with the device. Here's a general overview of the process:
Depending on the device classification, the required filing will differ:
The process for medical device certification in the United States primarily involves determining the device classification, submitting the appropriate FDA filing (510(k), PMA, or IDE), meeting GMP compliance, obtaining clearance or approval, and adhering to post-market surveillance and labeling requirements. The level of regulatory scrutiny depends on the device’s risk classification.
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