510(k): Format and Contents 2013

Topics

• Definitions and medical device classification including in vitro diagnostic medical devices
• Statute(s) and regulations governing 510(k)
• How to identify a suitable predicate device(s), if any
• Who should submit 510(k)s and when required to submit 510(k)s
• Recent changes in the 510(k) program
• How to demonstrate substantial equivalence
• Differences in contents of 510(k)s based on products
• Decision points during 510(k) review
• How to address the relevant and applicable regulatory requirements
• How to identify regulatory requirements relevant and applicable to the product(s)
• How to increase 510(k) submission quality for a product
• How to present your performance data and clinical data in a succinct, comprehensive manner
• How to resolve different opinions between the submitter and FDA reviewer(s)
• How to respond to FDA’s request of additional information

Who should Attend

• Specialists
• Regulatory Affairs Associates
• Directors and VPs · Quality Associates
• Managers
• Engineers
• Specialists
• Directors and VPs · Compliance Specialists and Officers · Research and Development (R&D) Managers
• Managers
• Directors and VPs · Complaint Handling and Risk Management Managers and Directors · Sales and Marketing Managers and Directors · Clinical Affairs Managers and Directors · Site Managers
• Directors and VPs · Product and Development (P&D) Managers
• And Consultants · Senior and Executive Management · Legal Counsel · Anyone Interested in learning about 510(k) process and submission
• Directors