The 510(k) Process and Risk Management

Why Should You Attend:

The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. FDA has continued to change this process after some controversy surrounding devices cleared for market. This controversy resulted in replacement of the Director of the Center of Devices and Radiological Devices. An internal report identified some issues and called for an external review of the process, which the FDA commissioned. Manufacturers need to continue to monitor the FDA communications on the 510(k) process.

This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products. The 510(K) process has begun to change and it is certain the process will continue to change. Manufacturers need to be prepared to defend medical device safety in their premarket applications. One of the tools that can be used to address the concerns over product safety that drives the FDA changes is Risk Management. We will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate the product is safe.

Areas Covered in the Webinar:

• What concerns were revealed in the internal report on the 510(k) process?
• What information can be gained from congressional statements?
• What is a "predicate" product in the 510(k) process?
• How can a manufacturer determine if the proposed product is as safe as the predicate device?
• How can a manufacturer best provide documentation in the 510(k) application demonstrating product safety?
• Current 510(k) process
• Changes to FDA 510(k) cleared product

Who will benefit:

The webinar is focused on the safety requirements of the US FDA Premarket Notification (510(k)) process, and applies to the manufacturers personnel responsible for creating documentation supporting the application. It is not limited to regulatory affairs personnel, but includes all of the design team that creates the document package.

• Regulatory Affairs
• Risk Managers
• Risk Management team members
• Quality Engineering
• Market Research
• Clinical
• MDR Reporters

Instructor Profile:

During his 26 year career in medical devices, Edwin Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Master’s degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the international technical committee. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at ELB Consulting in the area of medical device quality, regulatory, product liability and risk management.