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.
31 Mar-1 Apr 2020
& 22-23 Sep 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 24 Jan
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
to help ensure the successful submission of novel devices.
Demonstrations of how to find key information in FDA databases will be presented using participants’ products and interests as examples. There will also be updates on recent legislation changes, new regulations and guidance documents.
Please note that while the law, regulations, principles and processes covered in the course apply to both medical devices and in-vitro-diagnostics (IVDs), the trainer’s primary experience is with medical devices.
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.
|31 Mar-1 Apr 2020|
|31 Mar-1 Apr 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 24 Jan*
|22-23 Sep 2020|
|22-23 Sep 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
|Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.|
* Note the early booking discount cannot be combined with any other offers or promotional code