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.

16-17 Oct 2018

GBP 1,499
EUR 2,099
USD 2,338

Book now

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 prior to the initial submission of novel devices to help ensure a successful submission process. Finally, some “hot topics” will be presented. Depending on the interest of the participants, these may include new FDA requirements and policies involving Unique Device Identifier, regulation of device software, and how to distinguish device “enhancements” from being considered a recall.

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 “hot topics” and 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 organization
  • FDA 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
  • Do’s and don’ts

510(k) Process (Premarket 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

Premarket Approval (PMA) for Class III Devices

  • Content 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

Mark Kramer

Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.

He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.

Book now

16-17 Oct 2018
16-17 Oct 2018 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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