Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 510(k) Pre-IDE/IDE and PMA (Los Angeles, CA, United States - February 23-24, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 510(k) Pre-IDE/IDE and PMA" conference to their offering.

This workshop style training course is designed based on 30 years 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

Who Should Attend:

- 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:

Day 1 Schedule

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

For more information about this conference visit http://www.researchandmarkets.com/research/z7bh9w/preparing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices