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How to Decide When a Modified Device Requires a 510(K) Clearance
How to Decide When a Modified Device Requires a 510(K) Clearance

Our Price: $395.00

Product Code: WB-7155

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About the Product
Includes 1 hour and 5 minute Windows Media Video File and PowerPoint presentations for immediate download.

Determining when a modification to a legally marketed device triggers the need for a 510(k) is challenging. Industry practice and FDA’s expectations are frequently not aligned. This is evidenced by an uptick in FDA Warning Letters regarding design and claims-related changes to medical devices. The following presentation will:
  • Describe the FDA legal and regulatory framework governing the 510(k) implications of device modifications.
  • Analyze the recent Warning Letters on this issue and provide insights into FDA’s current thinking.
  • Outline the common pitfalls that industry encounters when evaluating device modifications, and provide a step-wise process for analyzing changes to 510(k)-cleared devices and 510(k)-exempt devices consistent with FDA’s expectations.

Pamela Forrest
King and Spalding

Lynette Zentgraft
King and Spalding

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Legal Counsel
  • Compliance Officers

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