Improving 510(k) submission quality
This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission ("510(k)") is made to US FDA.
Description:
This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission ("510(k)") is made to US FDA.
The 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 to demonstrate that the subject device (to be marketed or new device) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). During the 510(k) preparation, improving 510(k) submission quality can save significant amount of your business time, money, and resources by avoiding encountering lots of hurdles during the review process in a predictable and foreseeable manner.
To bring a product to market fast through the 510(k) program, it is imperative the medical device manufacturers understand the 510(k) processes with awareness of potential hurdles and be able to prepare 510(k)s in a way to proactively expedite the review process for timely clearance, potentially saving millions of dollars to the businesses. This 60-min webinar will greatly help you improve your 510(k) submission quality, inspiring you to take or choose to take different approaches when preparing your next 510(k)s.
Objectives of the presentation:
Statute(s) and regulations for 510(k)s
Definitions
Regulatory provisions, device classification, and product codes
What actions require 510(k)s (traditional, special, or abbreviated)
Who is subject to 510(k) submission
How to identify a suitable predicate device(s), if any
How to demonstrate substantial equivalence
510(k) program, processes, and decision points during 510(k) review
Differences in contents of 510(k)s based on products
Quality submission requirements
How to identify and address regulatory requirements and safety issues
Data summary and presentation
How to identify potential risks and establish risk criteria
Communication, interaction and negotiation with the FDA reviewers
Speaker's methods, tools, strategies, and much more.
Who can benefit:
Regulatory affairs managers, directors and VPs
Clinical affairs managers, directors and VPs
Quality managers, directors and VPs
Quality managers, directors and VPs
Compliance managers and directors
Sales and marketing managers, directors, and VPs
Complaint handling and risk management managers and directors
Site managers, directors, and consultants
Senior and executive management
Compliance officers and legal counsel
Business development managers, directors, and VPs
Time: 10:00 - 11:00
Venue: online, San Francisco
Cost: 243
More info:
online training