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FDA (Food and Drug Administration) 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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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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.

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.


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


Jonathan Hughes (More...)

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.


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at or contact us below:

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Continuing professional development

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

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 23-24 Mar 2022
  • 22-23 Jun 2022
  • 12-13 Sep 2022
  • 5-6 Dec 2022

Book now

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  • Baxter
  • Bayer Consumer Care AG
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  • Bespak Europe Ltd
  • Biosphere Medical SA
  • Boston Scientific Corp
  • CWT Russ LLC
  • Essity - BSN medical GmbH
  • Euro Diagnostica AB
  • Glycorex Transplantation AB
  • Jimro Co Ltd
  • JRI Orthopaedics Limited
  • Medtronic International Trading Sarl
  • Mobidiag Oy
  • OrthoMimetics Ltd
  • PA Consulting Group
  • Pfizer
  • Probus Regulatory Services Ltd
  • Sanofi-Aventis Deutschland GmbH
  • Sharp Life Science (EU) Ltd
  • Siemens Healthcare GmbH
  • Sinclair Pharma
  • Smiths Medical International Ltd
  • Stanmore Implants Worldwide Limited
  • Xiros Ltd

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 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

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] 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, Oct 18

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, Oct 18

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 18

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, Apr 18

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 18

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 18

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

Matteo Lostuzzo, Regulatory Affairs Manager, Biotronik AG, Apr 18

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 17

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

Louise Bateman, Quality Manager, Bedfont Scientific Ltd, Apr 17