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2-day In-person Seminar on Prepare and Submit 510(k) Premarket Notification Submissions for Success at Minneapolis

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The majority of medical devices commercialized in the United States require a 510(k) submission, which is used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device, meaning a device that is legally marketed and is not subject to a PMA. Many companies planning to introduce a medical device to the US market need to submit an application to the FDA called a 510(k).

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