Preparing a FDA 510(k) Submission

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 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 software.

In this webinar join expert speaker Edwin Waldbusser, where he will discuss contents and format for a Q-submission and 510(k) compliant with the FDA's, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner.

Session Highlights:

• 510(k) unique terminology

• 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
  

Why You Should Attend:

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.

Who Should Attend:

• Regulatory affairs professionals

• Engineering personnel

• QA
  

• Software developers
  

• IT personnel
  

• Management
  

• Regulatory personnel 

• R&D personnel

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.