This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices.
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the “general controls” applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications.
Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the “pre-submission” process, which FDA strongly recommends prior to the initial submission of novel devices to help ensure a successful submission process. Finally, some “hot topics” will be presented. Depending on the interest of the participants, these may include new FDA requirements and policies involving Unique Device Identifier, regulation of device software, and how to distinguish device “enhancements” from being considered a recall.
Upon completion of this seminar, participants will:
This seminar is intended for regulatory, technical, clinical and quality professionals who require an understanding of the FDA medical device approval process. Management, legal, medical, marketing and other professionals who are interested in understanding the key principles of the medical device approval process will also benefit in attending.
Overview of US Medical Device Regulatory Principles
Pre-Submissions
510(k) process (Premarket Notification)
De Novo Applications for Low-Moderate Risk Devices
Investigational Device Exemption (IDE) for Clinical Investigations
Premarket Approval (PMA) for Class III Devices
Humanitarian Device Exemptions
Mark Kramer
Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.
He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.
| 12-13 Mar 2019 | |||
| 12-13 Mar 2019 | Cavendish Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
| 17-18 Sep 2019 | |||
| 17-18 Sep 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
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“I met Mark Kramer in a previous course of Combination Products. His explanations are very clear, I can perceive that he knows how FDA works, what FDA expects to get for every situation. I have enjoyed a lot and think it's been very profitable. Mark answered all our questions being pretty interactive. The course is about a general and consistent view of the FDA approval processes for medical devices, clear and comprenhensive presentation. I can sense that Mark knows very well how FDA works and what FDA expects. Very profitable and highly recommended to catch a general knowledge. ”
Maria Jose Hijarrubia Ibrahim, Medical Devices Registers, Grifols S.A
“[The course] was all very good and very informative. Very informative content given by a very knowledgeable speaker on a complex area, but I now have a much better understanding of the overall submission processes. ”
Simon Collings, Director, IDC
“Mark was a very good speaker and it was clear from the start that he was very knowledgeable. The course was well structured, pitched at the right level for the attendees, in a clear and concise manner, with plenty of opportunity to ask questions. ”
Adam Williams, Senior Quality Engineer, Sharp Life Science (EU) Ltd
“Useful and interesting course. Good amount of practical knowledge, great availability of the speaker. ”
Matteo Lostuzzo, Regulatory Affairs Manager, Biotronik AG
“It really helped me to get a sense, a meaning, to all what I do in my company in relation to US registration. I found it great to have an overview and an easy way to find the guidance documents. ”
Giulia Bigogno, Regulatory Affairs Specialist, Biotronik AG
“Excellent! Lots of Q&A, interactive session make the topic fun. Speaker has lots of experiences and strategic thinking. ”
Cadence Tan, Senior Regulatory Affairs Manager, GSK Consumer Healthcare
“I immensely enjoyed Mark's presentation, he is a very good speaker - conveying information in a clear and comprehensive manner, attentive, and responsive to the participants' needs. ”
Christina Zavadsky, QARA Manager, Zilico
“Very good presentation and speaker ”
Jovila Dodi, Regulatory Affairs Specialist , Tornier SAS
“The content was correct, the presentation was easy to follow and the speaker presented good examples. ”
Elvira Estape Egea, Technician Regulatory Affairs, Diagnostic Grifols S.A.
“Money well spent”
Jonathan Kearns, Human Factors Engineer, Pfizer
“Great speaker, well prepared and presented. ”
Stephanie McGettrick, Senior RA Associate, Vascutek Ltd
“Very clear speaking and language used. Very knowledgable. ”
Holly Widnall, Project Manager, Bedfont Scientific Ltd
“The course was very informative and Mark was very helpful with all questions we had. ”
Louise Bateman, Quality Manager, Bedfont Scientific Ltd
“The content was correct, the presentation was easy to follow and the speaker presented good examples. ”
Elvira Estape Egea, Technician Regulatory Affairs, Diagnostic Grifols S.A.
“All excellent ”
Ahmed Abdullah Rajab, , Saudi Food and Drug Authority
“Great overview with relevant topics covered ”
Katie Menchi, Regulatory Affairs Manager, Sinclair Pharma Plc
“Informative content, nice and clear presentation, and very knowledgeable speaker”
Jiao Chen, Regulatory Affairs Engineer, JRI Orthopaedics Limited
“This is a well run and informative course, Mark is a great presenter and reacts well to questions ”
Tim Allard, Regulatory Affairs, Quanta Dialysis Technologies Ltd
“Speaker is very knowledgeable. Contents are very informative and presentation was nice and clear. ”
Jiao Chen, Regulatory Affairs Engineer, JRI Orthopaedics Limited
“Excellent content, presentation and speaker ”
Caroline Beevers, Regulatory & Risk manager, Quanta Dialysis Technologies Ltd
“Very well presented. Course materials were good”
Rob Hyson, , RSB Projects Ltd
“Content was just what I needed. Very helpful. ”
Annette Callaghan, Managing Director, Annette Callaghan Ltd