RAPS Approved Webinar
Navigating the 510(k), IDE and PMA Submission and Approval Process
Date & Time: Course "Navigating the 510(k), IDE and PMA Submission and Approval Process" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Instructor Profile: Wednesday, August 22, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
John E Lincoln Consultant, Medical device and Regulatory affairs,
(for one participant)
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. The 21 elements of the 510(k). What is an IDE, and what is its format and role. The tailored FDA approach to the PMA. The broad range of U.S. FDA / regulatory issues to be considered by a company approaching the introduction of a new or changed device will be discussed, whether domestically manufactured or imported. How changes are addressed with each format. Such issues are taking 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 new product review process -- all of which is being demanded by a public tired of on-going news of new product failures. A review of recent information from the Agency, as well Agency steps that have already been translated into action in the past two years will provide direction in areas of concern and what to expect in the future.
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
Areas Covered in the Session: Suggest a Topic l l
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Tougher Expectations / Requirements The 510(k) -- Pre-market 'notification' and FDA Device Clearance
Your Necessity is our Priority
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
Click here to register for this webinar Who Will Benefit: l l l l l l l l
Senior management in Devices and Combo Products QA RA R&D Engineering Production Operations Consultants
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,
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Published on Aug 21, 2012
Overview: This webinar will evaluate medical device review routes under Exempt, 510(k) / PMN, and PMA, as both a process and as documentatio...