A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers to demonstrate that their device is safe and effective for its intended use. The process is required for devices that are not exempt from premarket notification requirements. This article outlines the steps involved in obtaining a 510(k) clearance.
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A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.
Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device itself...
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One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing the...
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For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people...
