A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (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)
It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the new requirements. What triggers the review time most is 510(k) submission quality, which greatly helps to expedite the review process. To facilitate the review process in a proactive and streamlined manner, this webinar is intended to walk you through strategies, tools, and methods for a successful 510(k) submission and clearance.
Why Should you Attend:
If you don't know the answers to the following questions, you should attend this webinar.
Applicable statute(s) and regulations
What is 510(k)?
What are the regulatory requirements for 510(k) submission?
How to choose suitable predicate(s)
How the medical devices are classified
What are the common deficiencies in 510(k) submissions?
How to improve 510(k) submission quality and address the applicable regulatory requirements
How to effectively use the FDA guidance documents and voluntary standards
How to ask and respond to questions and communicate with the FDA reviewers
How to resolve different opinions in interpreting the requirements
How to facilitate the review process to get it cleared fast.
Objectives of the Presentation:
Applicable statute(s) and regulations
What is 510(k)?
What are the regulatory requirements for 510(k) submission?
How to choose suitable predicate(s)
How the medical devices are classified
What are the common deficiencies in 510(k) submissions?
How to improve 510(k) submission quality and address the applicable regulatory requirements
How to effectively use the FDA guidance documents and voluntary standards
How to ask and respond to questions and communicate with the FDA reviewers
How to resolve different opinions in interpreting the requirements
How to facilitate the review process to get it cleared fast.
Who can Benefit:
Regulatory Affairs Associates, Specialists, Managers, Directors and VPs
Quality Associates, Specialists, Engineers, Managers, Directors and VPs
Compliance Specialists and Officers
Research and Development (R&D) Managers, Directors and VPs
Product and Development (P&D) Managers, Directors and VPs
Complaint Handling and Risk Management Managers and Directors
Sales and Marketing Managers and Directors
Clinical Affairs Managers and Directors
Site Managers, Directors, and Consultants
Senior and Executive Management
Legal Counsel
Anyone Interested in learning about 510(k) process and submission.
Click here for more information
http://www.onlinecompliancepanel.com/
Tuesday, September 25, 2012
10:00 AM PDT | 01:00 PM EDT
Live Session for one participant
Price: $243.00
Corporate Live Session 4 to 10 participants in single location.
Price:$986.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00
