Conference Description:
Why you should attend: The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. Recently FDA has indicated it is tightening this process after some controversy surrounding devices cleared for market. An internal report identified some issues and called for an external review of the process, which was recently released. Manufacturers need to prepare for the impact to product clearance process for the US market.
Areas Covered in the Session:
What concerns were revealed in the internal report on the 510(k) process?
What information can be gained from congressional statements?
What is a "predicate" product in the 510(k) process?
How can a manufacturer determine if the proposed product is as safe as the predicate device?
How can a manufacturer best provide documentation in the 510(k) application demonstrating product safety?
What changes to the 510(k) process have already been implemented?
When can further changes to the 510(k) process be expected?
Who Will Benefit:
Regulatory Affairs
Risk Managers
Risk Management team members
Quality Engineering
Market Research
Clinical Research
Project Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Start Date: 2011-09-08
Last Day: 2011-09-08
Deadline for abstracts/proposals: 2011-09-08
Contact Person: webinar
Email: webinars@globalcompliancepanel.com
Address:
online training webinar, Wilmington, DE, 19801, United States
Tel: 800-447-9407
Fax: 3022886884
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