Understanding Crucial Issues in the 510(k) Process 2014

Topics

• 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)?

Who should Attend

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