510(k): Submission and Clearance

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.
 
 
Sept. 19, 2012 - PRLog -- Description:
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/ecommerce/webinar/~p...

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
End
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