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.
16-17 Sep 2019
& 31 Mar-1 Apr 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 9 Aug
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.
For information while the law, regulations, principles and processes covered in the course apply to both medical devices and in vitro diagnostic (IVD) devices, the tutor’s primary experience is with medical devices rather than IVDs.
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
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
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.
|16-17 Sep 2019|
|16-17 Sep 2019||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 9 Aug*
|31 Mar-1 Apr 2020|
|31 Mar-1 Apr 2020||Venue not yet confirmed||
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code