How to Prepare a 510(k) Submission
Product Id : MD3392
Category : FDA Compliance, Medical Devices
Presenter : Edwin Waldbusser
Scheduled On : April 21 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
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. The requirements for preparing a 510(k) for a device modification will be discussed following the newly released guidance.
Areas Covered in the Session :
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
Who Should Attend:
Quality Assurance Departments
Regulatory Affairs Departments
Engineering Departments
Research and Development Departments
IT Departments
Software Developers
