Understanding Crucial Issues in the 510(k) Process 2014 is a webinar that covers topics such as:
- How to determine if a product is substantially equivalent to a previously marketed device (referred to as a "predicate device")
- How FDA classifies devices
- When a change to a previously submitted cleared 510(k) will require that the company submit a new 510(k) to cover the change. Here, we also will review several programs -- known as Special or Abbreviated 510(k)’s -- FDA has implemented that allow companies to make changes to 510(k)’s and sidestep some of the more typical requirements in a "traditional" 510(k)
- Challenges presented when a device differs from a predicate device – can you still use that predicate to support your 510(k)?
Understanding Crucial Issues in the 510(k) Process 2014 is intended for professionals from medical device companies, including vitro diagnostic industry, with responsibility in the following areas::
- Regulatory Affairs
- Senior Management
- Clinical Operations
- Research and Development
- Medical
- Legal
- Operations and Manufacturing
- Quality Assurance
- Sales
- Marketing
