Preparing a 510(k) Submission That Meets All FDA Requirements

Product Id : FDA152
Instructor : Edwin Waldbusser
Nov 16, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Medical device manufacturers have to go through a tough regulatory process known as premarket submission 510(k) to demonstrate to the FDA that their device is safe and effective. 510(k) has a high rate of rejection (almost 50%), mainly, due to missing or lack of appropriate documentation. Not only is the process time-consuming and complex, the requirements refer to many unfamiliar concepts and terms that can baffle even the experts.

Device manufacturers and marketers must understand though, that it is against the FDA’s interest to constantly return back applications for lack of information or to get more information because they have their own targets to meet. Start off on the right foot with your FDA reviewer by providing all the necessary information on your 501(k).

Join us for this webinar with medical device consultant Edwin Waldbusser to learn how to prepare a 501(k) submission that meets all FDA requirements. Learn each step of the procedure and all the various types of submissions, as well as get clarity on the confusing concepts of predicate device and “substantial equivalence.” You will also learn how to find and acceptable predicate device and understand FDA’s requirements for medical device software. Finally, Edwin will discuss the requirements for preparing a 510(k) for a device modification in accord with newly released guidance.

Session Highlights:

  • Understand the unique terminologies in 510(k)
  • The new “Refuse To Accept” policy and what it is
  • What is a predicate device
  • Selecting a predicate device (substantial equivalence)
  • Where to find substantially equivalent predicate devices
  • FDA requirements for medical device software
  • 510(k) procedure for a device modification in accordance with new guidance

Who Will Benefit:

  • Regulatory affairs professionals
  • Engineering personnel
  • QA
  • Software developers
  • IT personnel
  • Management
  • Regulatory personnel
  • R&D personnel
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.


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