Live Webinar
on
FDA's New Draft Guidance on Medical Device Changes and the 510(k)
Date & Time: Wednesday, September 07, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
(for one participant)
Overview: This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Now a new draft guidance document from the FDA is designed to add more consistency to this process: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. In addition, growing high-profile field problems indicate that change control and it's effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the
U.S. and take a renewed look at "grandfathered" product by the Agency is another result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the recommended fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.
Areas Covered in the Session:
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Instructor Profile: John E Lincoln Consultant, Medical device and Regulatory affairs, 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 peerreviewed 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 FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator
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