Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017 covers topics such as:
- Title 21 Code of Federal Regulations (CFR) for Medical Devices
- Food, Drug and Cosmetic Act (FD&C Act)
- Premarket Approval (PMA)
- Premarket Notification (510k)
- Points to Consider for preparing a Successful Premarket Submission
- Investigational Exemption Device (IDE)
- Post Market Requirements of Medical Devices
- Tips and Suggestions on interacting with FDA Officials
Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017 brings together:
- Marketing Professionals
- Regulatory Affairs Professionals (associates, specialists and managers)
- Quality Assurance and Quality Engineers
- Research & Development - Product Managers
- Buyers/Purchasing Professionals
- Project Managers responsible for United States
- Students majoring in Regulatory Affairs