Live Webinar
on
FDA's Revised [Draft] Guidance on Medical Device Changes and the 510(k)
Date & Time: Tuesday, January 25, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
John E Lincoln Consultant, Medical device and Regulatory Affairs
This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011.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). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format . Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.
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FDA Device Clearance / Changes in Direction The New Draft Guidance on Product Changes and Filing a New 510(k) The New Guidance on Manufacturing, Labeling, Tech/Performance and/or+B41 Materials Changes
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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Senior management in Devices and Combo Products QA RA R&D Engineering Production Operations Consultants
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