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

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:

History and background of U.S FDA Laws and Regulations
Classify Your Device
Choose the Correct Premarket Submission for your device
Compile the Appropriate Information for your Premarket Submission
Author and Prepare your Premarket Submission
Submit your Premarket Submission to the FDA
Interact with FDA Staff during Review and Approval
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

Speaker and Presenter Information

Subhash R Patel

Regulatory Affairs & Quality Compliance Consultant, MD Reg Consulting, LLC

Subhash Patel is an accomplished Regulatory Affairs Professional offering 30 plus year of experience in authoring, preparing and submitting more than 150 successful premarket submissions to U.S. FDA. He brings his expert knowledge and hands-on experience in developing a robust premarket submission that secures clearance or approval from U.S. FDA. He offers valuable tips and suggestions on "what works and what doesn't" form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries.

He is a Fellow of world's renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS. He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.