Course offering number:1003-703
Course ID:
2375
FDA Quarterly Briefing: Focus on Medical Device News–March 2010
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
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: CDRH Reorganization:
• Effects of the "revolt"
• New contact and committee plans
• Streamlined procedure
Module 2: 513 Exemptions:
• How to apply
• Criteria for approval
• 510(k) strategy
Module 3: IPMA Clinical Testing Requirements:
• Evidence of safety
• Evidence of efficacy
• Long term effects
Question and Answer Session