The 21 Elements of a 510(k) - Webinar by ComplianceOnline

This 90-minute webinar will review the 21 basic elements that need to be addressed in the traditional 510(k) submission, as required by the FDA.

Why Should You Attend:

The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. 

Areas Covered in the Seminar:

• The Three Types of 510(k)s and Their Uses.
• The 21 Required Elements in the 510(k), and How Documented.
• Finding, Proving and Documenting Substantial Equivalence.
• Addressing Product "With-" or "As-software" Issues.
• The "Statement" or The "Summary".
• Documenting "Hazards Analysis", and the MAUDE Database.
• The Declarations.
• U.S. FDA Device Clearance Process.

Who Will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering