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We will explain what a 510(k) is, and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of the predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on-device software. We will cover the requirements for the software. The requirements for preparing a 510(k) for a device modification will be discussed following the newly released guidance.


  • Unique terminologies in 510(k)
  • What is Refuse to Accept policy?
  • What is a predicate device?
  • Selecting a predicate device (substantial equivalence)
  • Where to find substantially equivalent predicate devices?
  • How to handle software?
  • 510(k) procedure for device modifications

The audience will gain the knowledge to prepare a successful 510(k) submission.


  • Engineering personnel
  • QA
  • Software developers
  • Management
  • Regulatory personnel

Edwin Waldbusser is a consultant retired from industry after 20 years of experience in the management of the development of medical devices (5 patients). He has been consulting in the areas of design control, risk analysis, and software validation for the past 8 years. He has a B.S. in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 lead auditor and a member of the Thomson Reuters Expert Witness network.

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