Course offering number:0912-707
Course ID:
2358
FDA Quarterly Briefing: Focus on Medical Device News–December, 2009
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
According to the FDA “Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing
regulatory controls.” New FDA guidelines, regulations and interpretations emerge constantly from the agency that controls almost a third of the
US economy. Keeping up with these changes is a constant challenge. Join CfPA each quarter for the latest FDA guidelines focused on the
medical device industry– 90 minutes with an expert who can help you assimilate the information and answer your questions.
This course is designed for professionals primarily in the medical device industry. However, interested parties in the pharmaceutical and
biotechnology and biologics fields will also benefit from this update. It will be especially beneficial to:
• Regulatory/QA Managers
• Directors and VPs
• Planning Executives anticipating FDA changes
Description
This quarter's briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and innovations from the
FDA, and places them in context for the medical device professional. This 90-minute accredited online training is divided into three sections,
each section devoted to a new FDA regulation or initiative. The topics for this quarter are:
Module 1: Major revisions:
• De Facto Elimination of 510(k)
• Center Reorganization
• New Clinical Testing Requirements
Module 2: Post market surveillance:
• Reporting Form Changes
• Long Term Testing
• Grandfathered Devices
Module 3: International harmonization:
• Progress with EMEA
• Predicate Device Set Backs
• Japan Harmonization Update
Question and Answer Session
> About Medical Device Summit
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website at >> www.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.