2014-08-08 13:57:10 -
This webinar is intended to discuss regulatory requirements for FDA 510(k)s: in particular, 510K) preparation, submission and a successful clearance under the current FDA situation.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). 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(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, 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 the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance.
At the end of this webinar, you will become better aware of the FDA 510(k) concerning recent trends, new strategy, submission and FDA clearance. You will plan and execute your practice differently in a more effective manner using the speaker’s guidance – CAC-SI method.
Why should you attend :
This webinar is intended to present regulatory requirements for 510(k)s including 510(k) preparation, submission and clearance.
Areas Covered in the Session:
Statute(s) and regulations
Definitions and medical device classification including IVDs
When is required to submit a 510(k)
De Novo process – practical advice
How to demonstrate substantial equivalence
510(k) contents and format
Technical and regulatory requirements
How to present your performance data and clinical data in a succinct, comprehensive manner.
How to increase 510(k) submission quality for a product.
How to respond to FDA’s request of additional information.
How to resolve different opinions between the submitter and FDA reviewer(s).
Best practices for 510(k) submission and clearance
Speaker’s PASS-IT recommendations