Event Detail
Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel
August 22, 2012 - Online Training DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Overview: This webinar will evaluate medical device review routes under Exempt, 510(k) / PMN, and PMA, as both a process and as documentation / submissions. The 510(k) process and submission documentation, the role of the IDE, and the PMA process and submission documentation will be evaluated and discussed. Why should you attend: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed. What are the steps and how are they documented? How is 510(k) vs PMA determined. What should be included, and what should only be referenced. What new concerns need to be addressed now? How can companies make such determinations? What approaches are required for product changes; for process changes? What about software "in-" or "as-product"? How does ISO 14971 Risk Management fit into the clearance / approval process? How to maximize the compilation process against scarce resources. Areas Covered in the Session: Tougher Expectations / Requirements The 510(k) -- Pre-market 'notification' and FDA Device Clearance Predicates and Substantial Equivalence Intended Use / Indications for Use The IDE -- Investigational Device Exemption; IRB's; Disclosures Clinicals -- the 'basics' The PMA -- Pre-market Approval Resolving a "Wrong" Decision Who Will Benefit: Senior management in Devices and Combo Products QA RA R&D Engineering Production Operations Consultants John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00