2014 - Understanding FDAs Recent 510(k) Guidance and New Requirements

Instructor: David Lim
Description:
This webinar is intended to discuss the recent changes, hurdles, and requirements for premarket notification [510(k)] compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD & C Act or the Act) describes the premarket notification requirements. The FDA [510(k)] guidance is the most common pathway to market for medical devices. The 510(k) is made 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. Recent implementation of both eCopy program and RTA policy necessitates medical device industry to pay a special attention to the 510(k) process. In addition, FDA recently finalized the 510(k) guidance.
It is imperative that the medical device manufacturers accurately understand and interpret the recent changes and the applicable regulatory requirements so that it can be adequately addressed in 510(k) s.
This webinar will provide ample opportunities to streamline your 510(k) preparation and submission in a way to adequately meet both eCopy and RTA policy and save a significant amount of time, energy, and resources.
Why Should you Attend:
It is important to ensure you are familiar with the latest FDA guidance so that you can demonstrate substantial equivalence of your device to a predicate(s) pursuant to the statutory requirements as set out in the FDA guidance document.
It is also time to ensure you streamline your 510(k) preparation, 510(k) submission and 510(k) clearance in a highly efficient, effective manner.
Objectives of the Presentation:
Laws and regulations
Definitions
FDA's recent guidance document
New 510(k) requirements
Refuse to accept (RTA) policy
eCopy program
Who/when it is required to submit a 510(k)
Regulatory requirements: performance testing
510(k) content and format
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).
Common mistakes
Best practices: PASS-IT solutions
Who can Benefit:
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality professionals (associates, specialists, managers, directors or VPs)
R & D (engineers, scientists, managers, directors or VPs)
Complaint and risk management personnel
Consultants
Contractors/subcontractors
CEOs
VPs
Clinical affairs (associates, specialists, managers, directors or VPs)
Other interested parties
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