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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.

12-13 Sep 2022

& 5-6 Dec 2022 , 21-24 Mar 2023 , 21-22 Jun 2023 , 18-19 Sep 2023 , 4-5 Dec 2023

Book or reserve now

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.

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). 

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 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

Presenter

Jonathan Hughes (More...)

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.

Book now

Book or reserve now

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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
12-13 Sep 2022
Live webinar
09:15-17:00
UK (London)
12-13 Sep 2022
Live webinar
09:15-17:00
UK (London)
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
to attend Live webinar
5-6 Dec 2022
Face-to-face, Rembrandt Hotel London
09:15-17:00
UK (London)
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*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
21-24 Mar 2023
Live webinar
13:15-16:30
UK (London)
21-24 Mar 2023
Live webinar
13:15-16:30
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 14 Feb 23*
Enrol now
to attend Live webinar
21-22 Jun 2023
Live webinar
09:15-17:00
UK (London)
21-22 Jun 2023
Live webinar
09:15-17:00
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 17 May 23*
Enrol now
to attend Live webinar
18-19 Sep 2023
Face-to-face, Rembrandt Hotel London
09:15-17:00
UK (London)
18-19 Sep 2023
Face-to-face
Rembrandt Hotel London
09:15-17:00
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 14 Aug 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
4-5 Dec 2023
Live webinar
09:15-17:00
UK (London)
4-5 Dec 2023
Live webinar
09:15-17:00
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 30 Oct 23*
Enrol now
to attend Live webinar

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.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • 3M Healthcare Ltd
  • Annette Callaghan Ltd
  • Arakis Ltd
  • ARROW INTERNATIONAL INC
  • Bibra Toxicology Advice & Consulting Ltd
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Cambridge Design Partnership
  • Carl Zeiss Meditec
  • Covidien (UK) Commerical Limited
  • DePuy International Limited
  • Diasorin S.p.A
  • GAMA Healthcare Ltd
  • HemoCue AB
  • IDC
  • ING. ERICH PFEIFFER GmbH
  • Janssen Pharmaceutica NV
  • JOHNSON & JOHNSON
  • Johnson & Johnson Medical Ltd
  • Leo Pharma A/S
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Novartis Vaccines & Diagnostics AG
  • Ortho-Clinical Diagnostics (Johnson & Johnson)
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Rising Tide
  • SGR Consulting Services Ltd
  • Teleflex Medical
  • Ultromics Ltd
  • UNIVERSITY OF BRISTOL
  • University of Manchester Intellectual Property Ltd
  • Wellspect Healthcare

I think it was great, a lot of helpful materials.

Tyler Beaverson, Technical Advisor, NAMSA, Jun 22

I found the webinar to be very informative, the speaker was very experienced in the area and was clearly an SME.

Liam O'Malley, R&D Project Manager, Teva Pharmaceuticals Runcorn, Jun 22

Jonathan was very knowledgeable and experienced in the industry, he took the time to answer questions from the participants thoroughly.

Sophie Edmonds-Allen, R&D Senior Scientist Human Factors, Teva Pharmaceuticals Runcorn, Jun 22

Absolutely fantastic. I needed to be able to communicate more effectively with my Regulatory colleagues and I believe the information I have learned on this course will assist me to do that

Jenny Ramsey, Quality Engineer - Compliance, Pfizer R&D UK Ltd, Mar 22

All was great, no complaints!

Angelica Morreno, Regulatory Affairs Assistant, Sinclair Pharmaceuticals, Mar 22

I was hoping to get more information regarding 510(k) submissions. I am very happy that I got the opportunity to learn much more. I learned a lot and feel more confident about my understanding of the submission processes.

Natale Rolim, Project Manager, EpiGuard, Mar 22

I was happy to attend to this webinar and it was really useful and well-explained and organized.

Mireia Crosa, Regulatory and Compliance Specialist, Diagnostic Grifols, S.A., Mar 22

Very detailed and patient

Kavi Sharma, Clinical Project Manager, Ultromics Ltd, Mar 22

[Jonathan was] very detailed and patient

Kavi Sharma, Clinical Project Manager, Ultromics Ltd, Mar 22

A good and well thought out webinar with very intelligent presenter.

Ifesinachi Onyekaba, Research and Development Specialist, MEDTRON AG, Sep 21

Very useful overview of the FDA medical device pathways to market with valuable documentation.

Angela Sauerwald, VP Product Safety,Clinical & Regulatory Affairs at Essity, Essity - BSN medical GmbH, Sep 20

It was an excellent training and covers US FDA MD regulation framework. Workshops were very useful.

Ilker Yilmaz, International Regulatory Affairs Manager, GAMA Healthcare Ltd, Sep 20

The course was good and a thorough run through of the FDA approval process, with an easy to understand Mark Kramer.

Jens Johansen, QA/RA Director, RSP Systems, Mar 19

I’m very pleased with the overall learning objectives, presentations and the quality of the handout given at the course. Good presentation and good focus on driving the presentations forward. A bit difficult to coordinate presentation with time table given in handouts.

Jarle Mikalsen, CSO, Lyfstone, Mar 19

The course gives a very nice overview; especially valuable when you are just starting to considering to apply for FDA market clearance. (The speaker was) very knowledgeable about the FDA approval procedure for MDs in general. Mark is a good speaker, approachable, and he leaves plenty of room for discussion.

Ivo van Bostelen, Project Leader, MRC-Holland BV, Mar 19