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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.

★★★★★ "I found the webinar to be very informative, the speaker was very experienced in the area and was cle... more"

21-24 Mar 2023
+ 3 more dates

Need help?  Enrol or reserve

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

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.

Enrol or reserve

The FDA Approval Process for Medical Devices course will cover:

MODULE 1 – Overview of US Medical Device Regulatory Principles


Course Introduction


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

Enrol or reserve

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

Book FDA Approval Process for Medical Devices Live online/Classroom training

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

21-24 Mar 2023

Live online

13:15-16:30 UK (London) (UTC+00)
14:15-17:30 Paris (UTC+01)
09:15-12:30 New York (UTC-04)
Course code 12519

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

Until 14 Feb

View basket 

 
Not ready to book yet?

for 7 days, no obligation

21-22 Jun 2023

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 12718

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

Until 17 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

18-19 Sep 2023

Classroom
Rembrandt Hotel
London

09:15-17:00 UK (London)
Course code 12453

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

Until 14 Aug

  • 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

4-5 Dec 2023

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 12301

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

Until 30 Oct

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.

Reviews of IPI's FDA Approval Process for Medical Devices training course


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

Jun 22 2022

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

Jun 22 2022

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

Tyler Beaverson
Technical Advisor, NAMSA

Mar 23 2022

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

Jun 22 2022

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

Mar 23 2022

[Jonathan was] very detailed and patient

Kavi Sharma
Clinical Project Manager, Ultromics Ltd

Mar 23 2022

Very detailed and patient

Kavi Sharma
Clinical Project Manager, Ultromics Ltd

Mar 23 2022

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 23 2022

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 23 2022

All was great, no complaints!

Angelica Morreno
Regulatory Affairs Assistant, Sinclair Pharmaceuticals

Sep 15 2021

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

Ifesinachi Onyekaba
Research and Development Specialist, MEDTRON AG

Sep 16 2020

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 16 2020

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

Mar 12 2019

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 12 2019

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 12 2019

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

Oct 16 2018

I met Mark Kramer in a previous course of Combination Products. His explanations are very clear, I can perceive that he knows how FDA works, what FDA expects to get for every situation. I have enjoyed a lot and think it's been very profitable. Mark answered all our questions being pretty interactive. The course is about a general and consistent view of the FDA approval processes for medical devices, clear and comprenhensive presentation. I can sense that Mark knows very well how FDA works and what FDA expects. Very profitable and highly recommended to catch a general knowledge.

Maria Jose Hijarrubia Ibrahim
Medical Devices Registers, Grifols S.A

Oct 16 2018

[The course] was all very good and very informative. Very informative content given by a very knowledgeable speaker on a complex area, but I now have a much better understanding of the overall submission processes.

Simon Collings
Director, IDC ltd

Apr 17 2018

Useful and interesting course. Good amount of practical knowledge, great availability of the speaker.

Matteo Lostuzzo
Regulatory Affairs Manager, Biotronik AG

Apr 17 2018

Excellent! Lots of Q&A, interactive session make the topic fun. Speaker has lots of experiences and strategic thinking.

Cadence Tan
Senior Regulatory Affairs Manager, GSK Consumer Healthcare

Apr 17 2018

I immensely enjoyed Mark's presentation, he is a very good speaker - conveying information in a clear and comprehensive manner, attentive, and responsive to the participants' needs.

Christina Zavadsky
QARA Manager, Zilico

Oct 16 2018

Mark was a very good speaker and it was clear from the start that he was very knowledgeable. The course was well structured, pitched at the right level for the attendees, in a clear and concise manner, with plenty of opportunity to ask questions.

Adam Williams
Senior Quality Engineer, Sharp Life Science (EU) Ltd

Apr 17 2018

It really helped me to get a sense, a meaning, to all what I do in my company in relation to US registration. I found it great to have an overview and an easy way to find the guidance documents.

Giulia Bigogno
Regulatory Affairs Specialist, Biotronik AG

Apr 27 2017

The course was very informative and Mark was very helpful with all questions we had.

Louise Bateman
Quality Manager, Bedfont Scientific Ltd

Apr 27 2017

The content was correct, the presentation was easy to follow and the speaker presented good examples.

Elvira Estape Egea
Technician Regulatory Affairs, Diagnostic Grifols S.A.

Apr 27 2017

The content was correct, the presentation was easy to follow and the speaker presented good examples.

Elvira Estape Egea
Technician Regulatory Affairs, Diagnostic Grifols S.A.

Apr 27 2017

Very clear speaking and language used. Very knowledgable.

Holly Widnall
Project Manager, Bedfont Scientific Ltd

Apr 27 2017

Great speaker, well prepared and presented.

Stephanie McGettrick
Director of RA, MedAlliance

Apr 27 2017

Money well spent

Jonathan Kearns
Human Factors Engineer, Pfizer

Apr 27 2017

Very good presentation and speaker

Jovila Dodi
Regulatory Affairs Specialist , Tornier SAS

Apr 19 2016

This is a well run and informative course, Mark is a great presenter and reacts well to questions

Tim Allard
Regulatory Affairs, Quanta Dialysis Technologies Ltd

Apr 19 2016

Speaker is very knowledgeable. Contents are very informative and presentation was nice and clear.

Jiao Chen
Regulatory Affairs Engineer, JRI Orthopaedics Limited

Apr 19 2016

Great overview with relevant topics covered

Katie Menchi
Regulatory Affairs Manager, Sinclair Pharma Plc

Apr 19 2016

Very well presented. Course materials were good

Rob Hyson
RSB Projects Ltd

Apr 19 2016

Content was just what I needed. Very helpful.

Annette Callaghan
Managing Director, Annette Callaghan Ltd

Apr 19 2016

All excellent

Ahmed Abdullah Rajab
Saudi Food and Drug Authority

Apr 19 2016

Informative content, nice and clear presentation, and very knowledgeable speaker

Jiao Chen
Regulatory Affairs Engineer, JRI Orthopaedics Limited

Apr 19 2016

Excellent content, presentation and speaker

Caroline Beevers
Regulatory & Risk manager, Quanta Dialysis Technologies Ltd

United Kingdom

  • 3M Healthcare Ltd
  • 42 Technology Ltd
  • Acrobot Company Ltd
  • Alere Technologies AS
  • Allergan Limited
  • Annette Callaghan Ltd
  • Arakis Ltd
  • Bedfont Scientific Ltd
  • Bespak Europe Ltd
  • Bibra Toxicology Advice & Consulting
  • Biogen Idec Ltd
  • Bioquell UK Ltd
  • Britannia Pharmaceuticals Ltd
  • CAMBRIDGE BIOSTABILITY
  • Cambridge Design Partnership
  • Carl Zeiss Meditec
  • ConvaTec Ltd
  • ConvaTec UK Ltd
  • Corin Group Plc
  • Corin Limited
  • Covidien (UK) Commerical Limited
  • COZART
  • DCA Design International
  • Depuy CMW
  • DePuy International Limited
  • Ethicon, Division of Johnson & Johnson Medical
  • GAMA Healthcare Ltd
  • GBUK Limited
  • Glysure Limited
  • GSK Consumer Healthcare
  • Huntleigh Technology Limited
  • Hyaltech Ltd.
  • IDC ltd
  • Imperial College London
  • Industrial Design Consultancy Limited
  • Informa Healthcare Limited
  • Intelligent Ultrasound
  • Isotron Ltd
  • JOHNSON & JOHNSON
  • Johnson & Johnson Medical Ltd
  • JRI Orthopaedics Limited
  • KCI UK Holdings Ltd
  • Lifescan Scotland Ltd
  • MAGSTIM CO LTD
  • Magstim Company Ltd
  • MedAlliance
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mediqol Limited
  • Medtrade Products Ltd
  • Microvisk Technologies
  • NGPOD
  • Nobel Biocare
  • Norgine Limited
  • Olympus KeyMed Ltd
  • Optos plc
  • Ortho-Clinical Diagnostics (Johnson & Johnson)
  • OrthoMimetics Ltd
  • OrthoSon
  • Orthoson Ltd.
  • Owen Mumford
  • Owen Mumford Ltd
  • PA Consluting
  • PA Consulting
  • PA Consulting Group
  • Pan Medical Ltd
  • PEARSALLS LTD
  • Pfizer
  • Pfizer R&D UK Ltd
  • Probus Regulatory Services Ltd
  • Quanta Dialysis Technologies Ltd
  • Reckitt Benckiser
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Renishaw plc
  • RSB Projects Ltd
  • Russell Square Quality Associates Limited
  • Sagentia Limited
  • Sanguin International
  • Sauflon Pharmaceuticals Ltd
  • SGR Consulting Services Ltd
  • Sharp Life Science (EU) Ltd
  • Sinclair Pharma
  • Sinclair Pharma Plc
  • Sinclair Pharmaceuticals
  • Smith & Nephew Wound Management
  • Smiths Medical International Ltd
  • Speciality Fibres and Materials Limited
  • Sphere Medical Ltd
  • Stanmore Implants Worldwide Limited
  • Technology Partnership Plc
  • Teva Pharmaceuticals Runcorn
  • Tissue Science Laboratories PLC
  • Ultromics Ltd
  • UNIVERSITY OF BRISTOL
  • University of Manchester Intellectual Property Ltd
  • Unomedical Ltd
  • VASCUTEK LTD
  • Vectura Group plc
  • Wesley Coe Limited
  • Xiros
  • XIROS PLC
  • Zilico

Germany

  • Abbott GmbH & Co. KG
  • Abbott Products GmbH
  • Acandis GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Carl Zeiss AG
  • Dr Suwelack Nachf Gmbh & Co KG
  • Essity - BSN medical GmbH
  • HEXAL
  • ING. ERICH PFEIFFER GmbH
  • MEDTRON AG
  • Miltenyi Biotec GmbH
  • Olympus Surgical Technologies Europe
  • Pfenning Meinig & Partner
  • Roche Diabetes Care GmbH
  • Roche Diagnostics GmbH
  • Sanofi-Aventis Deutschland GmbH
  • Siemens AG
  • Siemens Healthcare GmbH
  • Stryker Leibinger GmbH & Co Kg

Ireland

  • ABBOTT IRELAND
  • Aerogen Ltd
  • Boston Scientific
  • Boston Scientific Ireland Ltd
  • Cook Ireland Ltd
  • ELAN PHARMA TECHNOLOGIE
  • Henkel Ireland Limited
  • INAMED AESTHETICS
  • Medtronic Ireland
  • Merit Medical
  • RESPIRONICS (IRELAND) LTD
  • SWORDS LABORATORIES LTD
  • Tech Group Europe

Switzerland

  • Bayer Consumer Health Devision
  • Biotronik AG
  • Celgene International Sarl
  • DSM Nutritional Products Ltd Branch Pentapharm
  • Imtool Sarl
  • Institut Straumann AG
  • ISS AG, Integrated Scientific Services
  • Medtronic International Trading Sarl
  • Nobel Biocare
  • Nobel Biocare AB
  • Novartis Vaccines & Diagnostics AG
  • Rising Tide
  • ZIMMER GMBH

Denmark

  • Engineers & Doctor As
  • Ferring Pharmaceuticals A/S
  • FERROSAN A/S
  • LAB Research (Scantox)
  • Leo Pharma A/S
  • Neurodan A/S
  • Novo Nordisk A/S
  • RSP Systems
  • RSP Systems A/S
  • Unomedical A/S
  • William Cook Europe ApS

France

  • Air Liquide Santé International
  • Becton Dickinson
  • Biosphere Medical SA
  • Boston Scientific Corp
  • Cabinet Michel Richebourg
  • CyberConseil
  • Galderma R&D
  • Guerbet
  • Sanofi-Aventis Groupe
  • Sanofi-Aventis R&D
  • Tornier SAS

Sweden

  • AstraZeneca AB
  • Baxter
  • BONESUPPORT AB
  • DENTSPLY Implants
  • Euro Diagnostica AB
  • Glycorex Transplantation AB
  • HemoCue AB
  • Mölnlycke Health Care AB
  • Q-Med AB
  • Wellspect Healthcare
  • XVIVO Perfusion AB

Italy

  • Diasorin S.p.A
  • Digitec S.r.l.
  • Eurofins Biolab Srl
  • Invatec SRL
  • Orthofix Srl
  • Sigea Srl
  • Sorin Group Italia srl

Netherlands

  • Aqtis Medical
  • Biotop Medical
  • Merck Sharp & Dohme
  • MRC-Holland BV
  • Philips Consumer Lifestyle
  • POLYGANICS BV

Spain

  • Diagnostic Grifols S.A.
  • Diagnostic Grifols SA
  • Diagnostic Grifols, S.A.
  • Grifols S.A
  • Grifols S.A.

Belgium

  • Fujirebio-Europe NV
  • IBA
  • Janssen Pharmaceutica NV
  • Oystershell NV

Austria

  • Baxter Innovations GmbH
  • MED-EL Medical Electronics
  • PRO-MED AG

Finland

  • Medix Biochemica
  • Orion Pharma
  • WALLAC OY

Saudi Arabia

  • Gulf Health Council
  • SAUDI FOOD & DRUG AUTHORITY
  • Saudi Food and Drug Authority

United States of America

  • ARROW INTERNATIONAL INC
  • NAMSA
  • North American Science Associates

Czech Republic

  • Contipro Pharma as
  • Teleflex Medical

Norway

  • EpiGuard
  • Lyfstone

Poland

  • LiNA Medical Polska Sp. z o.o.
  • LiNA Medical Sp. z o.o.

India

  • QUINTILES RESEARCH (INDIA) PRIVATE

Japan

  • Jimro Co Ltd

Russia

  • CWT Russ LLC

Turkey

  • NEMED Tibbi Urunler

Enrol or reserve

Run FDA Approval Process for Medical Devices Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy