How to Prepare a FDA 510(k) submission

Edwin-Waldbusser
Speaker: Edwin Waldbusser
Regulatory consultant
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Date: April 25th Tuesday
Time: 01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Product Code: 300207
Level: Intermediate
Key Take Away

This webinar will explain what the FDA 510(k) guidance is and the procedure to prepare the submission, the several types of 510(k), each part of the premarket notification – 510(k)submission including the very confusing concepts of predicate device and substantial equivalence.

Overview

Understand FDA 510(k) process for medical devices. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. We will cover the FDA regulations for medical devices software.

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 such as predicate device and substantial equivalence. More than half of all submissions are rejected. We will teach you to prepare a submission meeting all the FDA requirements.

Areas Covered in this Webinar
  • 510(k) unique terminology
  • Refuse to accept policy

Learning Objectives
  • Learn how to submit a FDA 510(k) application
  • What is a predicate device?
  • Selecting a predicate device (substantial equivalence)
  • Where to find substantially equivalent predicate devices
  • How to handle software

Who Will Benefit
  • Regulatory affairs (associates, specialists, managers, directors or VPs)
  • Quality professionals (associates, specialists, managers, directors or VPs)
  • R&D (engineers, scientists, managers, directors or VPs)
  • Risk management personnel
  • Operations Personnel (Medical/Pharma/Biotech)
  • Quality/Regulatory/Compliance Consultants
  • Validation/Verification/Documentation/Product/Process/Project (Mfg)
  • Clinical affairs (associates, specialists, managers, directors or VPs)
  • Engineering Personnel (Quality/Regulatory/Compliance)
  • Software Developers (Medical/Pharma/Biotech)
Speakers Profile
Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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