Course overview
Gain a comprehensive understanding of how medical devices achieve approval and clearance in the United States. This course provides a solid foundation in the legal and regulatory framework governing medical devices - covering essential topics such as device classification, establishment registration, and device listing.
With this foundation in place, you’ll explore the approval and clearance pathways for both new and modified devices, including 510(k), IDE, PMA, HDE, and De Novo applications. Each major submission type will be examined in depth - from application contents and review timelines to key guidance documents and FDA expectations.
You’ll also discover how to make the most of the FDA pre-submission process, a powerful tool the agency strongly recommends to help ensure the success of novel device submissions.
Interactive case studies will allow you to apply what you’ve learned, using FDA databases to research example products and deepen your practical understanding. The course content is fully up to date, reflecting the latest changes in legislation, regulations, and guidance.
Your trainer, Jonathan Hughes, brings current, hands-on experience with both medical devices and in vitro diagnostics (IVDs). Please note, however, that this course covers medical devices in general and does not include separate sessions dedicated to specific device types (such as IVDs or software).
CPD Hours: 12
Course Content
- Day 1
- MODULE 1 - Overview of US Medical Device Regulatory Principles
- MODULE 2 - Medical Device Definition, Classification, Device Listing & Establishment Registration
- Day 2
- MODULE 3 - Submissions
- MODULE 4 - Borderline & Combination Products
Speakers
Jonathan Hughes
Jonathan Hughes, Ph.D., FTOPRA, has over 35 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). He 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 US FDA, MDSAP, EU NB, Brazilian ANVISA and Chinese NMPA inspections. He has worked with all the major international regulatory agencies, in particular (multiple) Notified Bodies and US FDA, EU Competent Authorities, Japanese PMDA, Chinese NMPA.
Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. He 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.
