510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the coming year onward.
The 510(k) Third Party (3P) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. This establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P Review Program.
Course Objectives:
This webinar will also discuss amendments made to section 523 by the FDA Reauthorization Act of 2017, which directed FDA to issue draft guidance on the factors that are used to determine what class I or class II devices are eligible for review by an accredited person. The 3P Review Program is intended to enable FDA to focus its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by 3P Review Organizations, and to provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid decisions on 510(k)s than
Course Outline:
• The 3P Review Process
• The 9 Current FDA-Accredited 3P “Persons”
• Accredited Persons’ Qualifications
• General Categories of Device Subject to 3P
• Sites for Specific Elgible Device Listings
• Information Required
• Important exceptions
• Pros and Cons, Considerations
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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