Presented by
Management Forum
FDA (Food and Drug Administration) Approval Process for Medical Devices In-house Training
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.
★★★★★ "Excellent conference, speaker, material etc were perfectly balanced and understandable."
- Format: Live online
- 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).
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.
New
This course will cover:
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
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.
Reviews of IPI's FDA Approval Process for Medical Devices training course
Excellent conference, speaker, material etc were perfectly balanced and understandable.
Sep 10 2024
Andrew Pearce 
Corporate Quality & Regulatory Director, GVS
Jun 18 2024
This course is very informative and interactive and touched all aspects off Medical device approval process by FDA. Overall excellent, webinar logistics are surprisingly easy, Jonathan's presentation of FDA content is exemplary. Jonathan is a great educator and shared all his experiences.
Sai Prasad 
Global Clinical & Medical Advisor, Surgical Structural Heart, Edwards Lifesciences Corp
Jun 18 2024
Jonathan was really very excellent. Clearly has a thorough understanding of the FDA and is able to impart that knowledge incredibly well. The slides were extensive (Jonathan clearly put a lot of time and effort into these) and will be a great resource for me in the future.
Vikki Young
Head of Quality and Regulatory, Prothea Technologies
Jun 18 2024
Jonathan was a really good speaker and took his time to answer any of our questions. He was very knowledgeable.
Henry Bland
QARA Specialist, Adtec Healthcare
Sep 10 2024
I got useful information.
Ravi Prabaharan
Research and Technology Manager, Advanced healthcare ltd
Sep 10 2024
He's a real guru and he's also a very good teacher.
Juan Verde 
MD, MSc, IHU Strasbourg
Jun 18 2024
I think Jonathan was really knowledgeable and had an easy way to explain things. Very graceful and humble teacher, including everyone and making all feel ok to ask questions.
Christina Dahl
Regulatory Affairs Associate , Cencora
Nov 27 2023
Very knowledgable and well spoken.
Melissa Coelho 
Director of Clinical Operations, Medicenna Therapeutics Inc
Jun 21 2023
Overall I thought that this was an excellent webinar in all respects.
Cath Hossain
Senior Scientist, CPI
Nov 27 2023
I think the course was very helpful. And was very complex and my team spent almost all of our available time discussing it.
Natalia Lescura 
Project Manager, Instituto Pedro Nunes - PT502790610
Nov 27 2023
I think the course was very helpful.
Natalia Lescura
Project Manager, Instituto Pedro Nunes - PT502790610
Jun 21 2023
Very good and comprehensive, but also very intensive (lot of information). maybe three days instead of two.
Stefan Neu 
Clinical Evaluation Specialist, BÜHLMANN Laboratories AG
Jun 22 2022
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 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.
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.
Ivo van Bostelen 
Project Leader, MRC-Holland BV
Oct 16 2018
A general and consistent view of the FDA approval processes for medical devices, clear and comprenhensive presentation.
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 wanted to familiarise myself further with the topic and this had definitely been achieved. The instructor provided a comprehensive overview of the subject including the context and history which further built on the theoretical background.
Christina Zavadsky
QARA Manager, Zilico
Oct 16 2018
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
Louise Bateman
Senior Quality Assurance and Regulatory Affairs 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.
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
- AbbVie
- Acrobot Company Ltd
- Adtec Healthcare
- Advanced healthcare ltd
- Advanced Healthcare Ltd Unit 2-4
- 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
- Cencora
- ConvaTec Ltd
- ConvaTec UK Ltd
- CooperSurgical
- Corin Group Plc
- Corin Limited
- Covidien (UK) Commerical Limited
- COZART
- CPI
- Croma-Pharma GmbH
- DCA Design International
- De Soutter Medical
- Depuy CMW
- DePuy International Limited
- Ethicon, Division of Johnson & Johnson Medical
- FMP Ltd
- GAMA Healthcare Ltd
- GBUK Limited
- Glysure Limited
- GSK Consumer Healthcare
- GVS
- Haleon
- 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
- Mayborn Group
- MedAlliance
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Mediqol Limited
- Medtrade
- 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
- Owlstone
- Owlstone Medical
- PA Consluting
- PA Consulting
- PA Consulting Group
- Pan Medical Ltd
- PEARSALLS LTD
- Pfizer
- Pfizer R&D UK Ltd
- Probus Regulatory Services Ltd
- Prothea Technologies
- Prothea Technologies Limited
- 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
- ThermoFisher Scientific
- 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
- Bentley InnoMed GmbH
- Berlin Heart 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
- Merit Medical Ireland Ltd
- RESPIRONICS (IRELAND) LTD
- SWORDS LABORATORIES LTD
- Tech Group Europe
Switzerland
- Bayer Consumer Health Devision
- Biotronik AG
- BÜHLMANN Laboratories 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
France
- Air Liquide Santé International
- Becton Dickinson
- Biosphere Medical SA
- Boston Scientific Corp
- Cabinet Michel Richebourg
- CyberConseil
- Galderma R&D
- Guerbet
- IHU Strasbourg
- 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
- Nordeberg Medical AB
- Q-Med AB
- Wellspect Healthcare
- XVIVO Perfusion AB
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
Italy
- Diasorin S.p.A
- Digitec S.r.l.
- Epygon Italie srl
- Eurofins Biolab Srl
- Eurofins Medical Device Testing
- 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
- Venn Life Sciences ED B.V.
Belgium
- Fujirebio-Europe NV
- IBA
- Janssen Pharmaceutica NV
- Oystershell NV
- Rousselot
Spain
- Diagnostic Grifols S.A.
- Diagnostic Grifols SA
- Diagnostic Grifols, S.A.
- Grifols S.A
- Grifols S.A.
United States of America
- ARROW INTERNATIONAL INC
- Edwards Lifesciences Corp
- NAMSA
- North American Science Associates
- Thermo Fisher Scientific
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
Czech Republic
- Contipro Pharma as
- Teleflex Medical
Korea, Republic Of
- Dongguk University
- 동국대학교
Norway
- EpiGuard
- Lyfstone
Poland
- LiNA Medical Polska Sp. z o.o.
- LiNA Medical Sp. z o.o.
Portugal
- Instituto Pedro Nunes - PT502790610
- IPN
Canada
- Medicenna Therapeutics Inc
India
- QUINTILES RESEARCH (INDIA) PRIVATE
Japan
- Jimro Co Ltd
Malta
- Baxter Healthcare Corp
Russia
- CWT Russ LLC
Turkey
- NEMED Tibbi Urunler
Run FDA Approval Process for Medical Devices Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- 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:
