How to prepare a 510(k) FDA Submission

Speaker

Instructor: Edwin Waldbusser
Product ID: 705024

Location
  • Duration: 60 Min
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.
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Why Should You Attend:

Preparing a submission to get FDA approval for a new product is time consuming and confusing. The submission requirements refer to many unfamiliar concepts and terms. More than half of all submissions are rejected. We will teach you how to prepare a submission meeting all the FDA requirements.

This webinar will explain what 510(k) is and the procedure to prepare the submission. It will explain the several types of 510(k) and each part of the submission will be discussed. The very confusing concepts of 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 and it will also cover the requirements for software.

Areas Covered in the Webinar:

  • 510(k) unique terminology
  • What is a predicate device
  • New "Refuse to accept policy"
  • Electing a predicate device (substantial equivalence)
  • Where to find substantially equivalent predicate devices
  • How to handle software

Who Will Benefit:

  • Engineering personnel
  • R&D personnel
  • Regulatory personnel
  • QA
  • IT
  • Software developers
  • Management
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS 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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