The 510(k) Process and Risk Management 2011

This 510(k) and risk management webinar /training will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstration the product is safe.

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?

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