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Description

This seminar is intended to provide practical and actionable guidelines on premarket notification [510(k)] preparation and submission to the US Food and Drug Administration (FDA).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. 510(k) is the most common pathway to bring medical devices including in vitro diagnostic medical devices (IVDs) into the US market.
To obtain a clearance, the 510(k) is first submitted to the US FDA, demonstrating that the subject device (to be marketed) is substantially equivalent to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a 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.
To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand the statutory requirements to expedite the FDA review process leading to timely clearances.
In this 60-min seminar, the speaker will walk you through common mistakes, recent trends and customized strategy for a successful clearance. The speaker will further discuss how to improve submission quality, preventing avoidable delays and reducing review times.

Areas Covered in the Session