FDA's Guidance on Software and Device Changes and the 510(k)

OVERVIEW The FDA has provided two guidance documents on software and device changes, which provide information as to whether a new 510(k) is needed.
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company’s decisions are provided.
FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
WHY SHOULD YOU ATTEND
Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution in the FDA regulated industries should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required.
AREAS COVERED
• Medical devices 510k changes
• How to manage software and device changes in an FDA compliant manner
• FDA guidance documents
• FDA enforcement actions
• New FDA 510(k) submission

WHO WILL BENEFIT
• Pharmaceutical
• Medical Device
• Biotechnology
• Tobacco
• E-Liquid/Vapor

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