Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

Overview:

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

 

 

Agenda:

Lecture 1:

An overview of U.S. FDA Premarket Regulations

• History and background of U.S FDA Laws and Regulations
• How to Classify Your Device
• Choose the Correct Premarket Submission for your device

Lecture 2:

Premarket Notification 510(k)

• Applicable Laws, Regulations and Requirements for 510(k)
• Decide Type of 510(k)
• Compile the Appropriate Information for 510(k)
• Format and Content of your 510(k)

Lecture 3:

Premarket Notification 510(k) - continue

• Suggestions on What to Include or Exclude into your 510(k)
• Tips on authoring a reader's friendly and convincing 510(k)
• Critical Review of your prepared 510(k) for acceptability

Lecture 4:

Premarket Notification 510(k) - continue

• Determine risk and contingency plan for potential questions form the reviewer
• Points to Consider - Submit your 510(k) to FDA
• Interact with FDA staff during review and clearance of your 510(k)

 

Day 2 Schedule

Lecture 1:

Premarket Approval (PMA)

• Applicable Laws, Regulations and Requirements for PMA
• Decide Type of PMA
• Compile the Appropriate Information for PMA
• Format and Content of your PMA
• Suggestions on What to Include or Exclude into your PMA
• Tips on authoring a reader's friendly and convincing PMA

Lecture 2:

Premarket Approval (PMA) - continue

• Critical Review of your prepared PMA for acceptability
• Determine risk and contingency plan for potential questions form the reviewer
• Points to Consider - Submit your PMA to FDA
• Interact with FDA staff during review and clearance of your PMA

Lecture 3:

Investigational Device Exemption (IDE)

• Applicable Laws, Regulations and Requirements for IDE
• Purpose and Use of Pre-IDE to your advantage
• Compile the Appropriate Information for IDE
• Format and Content of your IDE
• Suggestions on What to Include or Exclude into your IDE
• Tips on authoring a reader's friendly and convincing IDE

Lecture 4:

Post Market Requirements for Medical Devices

• Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
• Mandatory Medical Device Reporting (MDR)
• Recalls, Corrections and Removals
• Medical Device Tracking
• Post Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic Act
• Post-Approval Studies (PAS) mandated as a condition of approval of a premarket submission - mostly premarket approval (PMA) application
• Points to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions

 

 

Speaker:

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.