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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course
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.
Details
Course overview
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.
Benefits of attending
Upon completion of this seminar, participants will:
- Understand the overall FDA medical device regulatory process
- Know what is required for 510(k), IDE, PMA, HDE and De Novo applications
- Understand how FDA processes premarket submissions
- Identify key guidance documents to help ensure a successful process
- Determine when pre-submission interaction with FDA is recommended
- Be aware of areas of change
Who should attend
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.
Programme
MODULE 1 – Overview of US Medical Device Regulatory Principles
Part 2 - Introduction to US FDA
History, Structure and Mission of FDA
Part 3 - Overview of US Regulatory Process and Pathway
Including how to work with FDA and pre-submissions (Q-subs)
MODULE 2 – Medical Device Definition, Classification, Device Listing & Establishment Registration
Part 1 - Medical Device Definition, Classification, Device Listing & Establishment Registration
Part 2 – Classification Case Study
MODULE 3 – Submissions
Part 1 - Pre-Market Notification 510(k)
Part 2 – De-Novo / Automatic Class III Reclassification
Part 3 - Pre-Market Approval (PMA)
Part 4 – HDE & IDE (& IUO)
Part 5 – Submission Case Study
MODULE 4 – Borderline & Combination Products
Product Designation & Combination Products
Presenter
Jonathan Hughes (More...)
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). 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 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. 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.
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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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22-23 Jun 2022 Live webinar 09:15-17:00 UK (London) |
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22-23 Jun 2022 Live webinar 09:15-17:00 UK (London) |
GBP 1,299.00 EUR 1,859.00 USD 2,098.00 + VAT @ 20.00% |
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to attend Live webinar |
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12-13 Sep 2022 Live webinar 09:15-17:00 UK (London) |
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12-13 Sep 2022 Live webinar 09:15-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 8 Aug* |
Enrol now
to attend Live webinar |
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5-6 Dec 2022 Face-to-face, Rembrandt Hotel London 09:15-17:00 UK (London) |
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5-6 Dec 2022 Face-to-face Rembrandt Hotel London 09:15-17:00 UK (London) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 31 Oct* |
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to attend Face-to-face Rembrandt Hotel London |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.