subject: The 510(k) Process and Risk Management - Webinar By ComplianceOnline [print this page] The 510(k) Process and Risk Management - Webinar By ComplianceOnline
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. Recently FDA has indicated it is tightening 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 prepare for the impact to product clearance for the US market.
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 seminar:
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?
What changes to the 510(k) process have already been implemented?
When can further changes to the 510(k) process be expected?
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:
Edwin L. Bills, During his 20 year career in medical devices, Mr. 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 Masters 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 this group.
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