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FDA 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.

22-23 Mar 2021

& 24-25 Mar 2021 , 13-14 Sep 2021 , 15-16 Sep 2021

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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.

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.

Programme

Overview of US medical device regulatory principles

  • FDA mission and organisation
  • FDA’s Center for Devices and Radiological Health (CDRH)
  • History and law
  • Device classification
  • General controls
  • Special controls
  • Product codes
  • Registration and listing
  • 513(g) process
  • e-Copy program
  • MDUFA (Medical Device User Fee Act)
  • Review performance goals
  • Finding information in FDA databases
  • 21st Century Cures legislation, FDARA and MDUFA IV

Pre-submissions

  • Types of pre-submissions
  • Contents of a pre-submission
  • Review timelines
  • Preparing for an FDA meeting
  • Dos and don’ts

510(k) process (pre-market notification)

  • History and purpose of 510(k) process
  • Traditional, special and abbreviated 510(k) submissions
  • Contents of 510(k) applications
  • Substantial equivalence decision making process
  • 510(k) review processes 
  • Acceptance screening of 510(k)s (‘Refuse to Accept’ policy)
  • Review timelines
    • Interactive review processes
    • 510(k) decisions
    • When a new 510(k) is needed for a device modification

    De Novo applications for low-moderate risk devices

    • De Novo reclassification process
    • Potential pros and cons of seeking De Novo Reclassification 
    • Contents of De Novo applications
    • De Novo decision-making process 
    • Review timelines

    Investigational device exemption (IDE) for clinical investigations

    • Significant risk, non-significant risk and exempt investigations
    • Contents of IDE applications
    • IDE review timelines
    • IDE decision-making process
    • FDA actions on IDE applications
    • 5-day notices 
    • IDE supplements
    • Annual reports
    • Sponsor responsibilities

    Pre-market approval (PMA) for Class III devices

    • Contents of PMA applications
    • PMA review standard
    • Acceptance screening and filing of PMAs
    • Phases of PMA review
    • Review timelines
    • Advisory panel review
    • Interactive review processes 
    • PMA decisions
    • PMA supplements
    • PMA reports
    • Post-approval requirements

    Humanitarian device exemptions

    • Humanitarian Use Designation (HUD)
    • HDE review standard
    • Contents of HDE applications
    • HDE review timelines
    • HDE supplements
    • HDE reports

    Presenter

    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.

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    Book now

    22-23 Mar 2021
    Face-to-face, (venue not yet confirmed)
    22-23 Mar 2021
    Face-to-face
    (venue not yet confirmed)
    GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 8 Feb 21*
    Enrol now
    to attend
    Face-to-face
    (venue not yet confirmed)
    • 2 days of 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
    24-25 Mar 2021
    Live webinar
    24-25 Mar 2021
    Live webinar
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 10 Feb 21*
    Enrol now
    to attend
    Live webinar
    13-14 Sep 2021
    Face-to-face, (venue not yet confirmed)
    13-14 Sep 2021
    Face-to-face
    (venue not yet confirmed)
    GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 2 Aug 21*
    Enrol now
    to attend
    Face-to-face
    (venue not yet confirmed)
    • 2 days of 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
    15-16 Sep 2021
    Live webinar
    15-16 Sep 2021
    Live webinar
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 4 Aug 21*
    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

    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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    • Glycorex Transplantation AB
    • Grifols S.A.
    • GSK Consumer Healthcare
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    • ING. ERICH PFEIFFER GmbH
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    • Janssen Pharmaceutica NV
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    • Medtrade Products Ltd
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    • Novo Nordisk A/S
    • Pfenning Meinig & Partner
    • Renishaw plc
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    • Sanofi-Aventis R&D
    • Technology Partnership Plc
    • Tornier SAS
    • William Cook Europe ApS

    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

    Very good presentation and speaker

    Jovila Dodi, Regulatory Affairs Specialist , Tornier SAS , Apr 17

    Money well spent

    Jonathan Kearns, Human Factors Engineer, Pfizer, Apr 17

    Great speaker, well prepared and presented.

    Stephanie McGettrick, Director of RA, MedAlliance, Apr 17

    Very clear speaking and language used. Very knowledgable.

    Holly Widnall, Project Manager, Bedfont Scientific Ltd, Apr 17

    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