Description :

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