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Management Forum

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.

19-20 June 2024
+ 10-11 September 2024, 2-3 December 2024 »
from £1099

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Format: Live online, Classroom
CPD: 12 hours for your records
Certificate of completion

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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.

Case studies will help participants to put some of the learnings into practice and to use FDA databases to research example products. The course includes up to date information which covers recent changes in legislation, regulations and guidance. Please note that the trainer has recent experience with both medical devices and in vitro diagnostics. However, please not that the course covers medical devices in general and does not provide separate sessions for specific types of medical devices (such as IVDs, software, etc).

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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.

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The FDA Approval Process for Medical Devices course will cover:

Day 1
Day 2

MODULE 1 – Overview of US Medical Device Regulatory Principles

Part 1 - Introduction to US FDA

History, Structure and Mission of FDA

Part 2 - 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

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Jonathan Hughes
JHRA Ltd

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.

More details

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

19-20 June 2024

Live online

09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 13735

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 15 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

10-11 September 2024

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 13897
Optional £240/€312/$360 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 06 Aug

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

2-3 December 2024

Live online

09:15-17:00 UK (London) (UTC+00)
10:15-18:00 Paris (UTC+01)
04:15-12:00 New York (UTC-05)
Course code 14068

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 28 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.