New York Professional Events List

Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

Apr 27, 2017 - 08:30 AM - Apr 28, 05:00 PM
NetZealous LLC
2001, Hospitality Ct

ZIP: 27560

This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:

  1. History and background of U.S FDA Laws and Regulations
  2. Classify Your Device
  3. Choose the Correct Premarket Submission for your device
  4. Compile the Appropriate Information for your Premarket Submission
  5. Author and Prepare your Premarket Submission
  6. Submit your Premarket Submission to the FDA
  7. Interact with FDA Staff during Review and Approval
  8. Complete the Establishment Registration and Device Listing

Why should you attend:

The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader's friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.

Areas Covered in the Session:

  • Food, Drug and Cosmetic Act (FD&C Act)
  • Title 21 Code of Federal Regulations (CFR) for Medical Devices
  • Premarket Notification (510k)
  • Premarket Approval (PMA)
  • Investigational Exemption Device (IDE)
  • Points to Consider for preparing a Successful Premarket Submission
  • Tips and Suggestions on interacting with FDA Officials
  • Post Market Requirements of Medical Devices

Who Will Benefit:

  • Regulatory Affairs Professionals (associates, specialists and managers)
  • Marketing Professionals
  • Research & Development - Product Managers
  • Quality Assurance and Quality Engineers
  • Project Managers responsible for United States
  • Buyers/Purchasing Professionals
  • Students majoring in Regulatory Affairs

Event Categories
Keywords: class , design , development , food , history , history, professional, research , sing, training


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