Presented by
Management Forum

FDA Approval Process for Medical Devices

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.

29-30 Mar 2022 + 3 more dates

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  • 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.

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.

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The FDA Approval Process for Medical Devices course will cover:

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

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Jonathan Hughes

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.

More details

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

29-30 Mar 2022

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 11588

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 22 Feb

In your basket 

15-16 Jun 2022

Classroom
London venue TBC

09:15-17:00 UK (London)
Course code 11367

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 11 May

  • 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

In your basket 

12-13 Sep 2022

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 11714

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 08 Aug

In your basket 

7-8 Dec 2022

Classroom
London venue TBC

09:15-17:00 UK (London)
Course code 11887

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 02 Nov

  • 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

In your basket 

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


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

Sep 15 2021

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

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

UK

  • 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
  • Carl Zeiss Meditec
  • ConvaTec Global Development Centre
  • ConvaTec UK Ltd
  • Corin Group Plc
  • Covidien (UK) Commerical Limited
  • COZART
  • DCA Design International
  • Depuy CMW
  • DePuy International Limited
  • Ethicon, Division of Johnson & Johnson Medical
  • GAMA Healthcare Ltd
  • GBUK Group
  • Glysure Limited
  • GSK Consumer Healthcare
  • Huntleigh Technology Limited
  • Hyaltech Ltd.
  • IDC
  • 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
  • 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
  • Smith & Nephew Wound Management
  • Smiths Medical International Ltd
  • Speciality Fibres and Materials Limited
  • Sphere Medical Ltd
  • Stanmore Implants Worldwide Limited
  • Technology Partnership Plc
  • Tissue Science Laboratories PLC
  • 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
  • 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
  • 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

Belgium

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

Spain

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

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

Poland

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

India

  • QUINTILES RESEARCH (INDIA) PRIVATE

Japan

  • Jimro Co Ltd

Norway

  • Lyfstone

Russia

  • CWT Russ LLC

Turkey

  • NEMED Tibbi Urunler

United States of America

  • ARROW INTERNATIONAL INC

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Multiple colleagues?
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

+44 (0)20 7749 4749

inhouse@ipi.academy