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

Apr 15, 2020 from 15:00 to 16:30 UTC+02
Location: Webinar
Latest Activity: Oct 12, 2020

OVERVIEWThe 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 ATTENDAnyone 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.The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness.After attending this seminar, you will be able to better navigate the processes required to determine how to manage software and device changes in an FDA-compliant manner.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) submissionLEARNING 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• Pharmaceutical• Medical Device• Biotechnology• Tobacco• E-Liquid/Vapor• E-Cigarette• CigarUse Promo Code TDES20 and get flat 20% discount on all purchases.To Register (or) for more details please click on this below link:http://bit.ly/2Wgg8SREmail: support@trainingdoyens.comToll Free: +1-888-300-8494Tel: +1-720-996-1616Fax: +1-888-909-1882

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

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