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
& 16-17 Sep 2020
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
Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.
Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). Jonathan has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.
Jonathan specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has a strong knowledge of quality management systems and has direct hands-on experience of EU NB, MDSAP, US FDA, Brazilian ANVISA and Chinese NMPA inspections. He has worked with all the major international regulatory agencies, in particular (multiple) Notified Bodies and EU Competent Authorities, Japanese PMDA, US FDA, Chinese NMPA.
Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. Jonathan is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes. Jonathan has registered teacher status at Cranfield University, is a Visiting Industrial Fellow at the University of Hertfordshire and also a visiting lecturer at University of Newcastle upon Tyne.
|31 Mar-1 Apr 2020|
|31 Mar-1 Apr 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
|16-17 Sep 2020|
|16-17 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.|