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
Who should Attend
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
Past Events
Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017 - 27-28 Apr 2017, Courtyard Raleigh-Durham Airport, Morrisville, North Carolina, United States (66795)
Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2016 - 05-06 May 2016, Courtyard Boston Logan Airport, Massachusetts, United States (58492)
Important
Please, check "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" official website for possible changes, before making any traveling arrangements
