2019 - How to Prepare a 510(k) Submission

OVERVIEW
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.
LEARNING OBJECTIVES
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
WHY SHOULD YOU ATTEND
The audience will gain the knowledge to prepare a successful 510(k) submission.
WHO WILL BENEFIT?
Engineering personnel
QA
Software developers
Management
Regulatory personnel
SPEAKER
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.
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