Live Webinar : 510(k): Format and Contents by Compliamce2go October 10, 2012

This webinar is intended to demonstrate how to prepare a 510(k) in a manner with increased submission quality with awareness for the successful review and clearance.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

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