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.
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

LEARNING OBJECTIVES
• Learn about the FDA’s latest guidance on medical devices 510k changes
• Understand the three key areas of change that are discussed in the FDA guidelines for medical devices
• Learn about the questions to ask and decisions to make, based on flowcharts provided by FDA
• Gain confidence that changes will more likely be approved, given a thorough examination and explanation of impact of the change and potential risk
WHO WILL BENEFIT
• Pharmaceutical
• Medical Device
• Biotechnology
• Tobacco
• E-Liquid/Vapor
• E-Cigarette
• Cigar

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http://bit.ly/2xKQmvN
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