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FDA's Two New Draft Guidance on Software and Device Changes and the 510(k) - Webinar

2016, December 14

Other » Training

This webinar will teach you how to use a series of flowcharts to evaluate whether or not a change to a medical device or to software requires a new draft guidance 510(k) submission, based on the type of medical device changes, and the impact on the safety and effectiveness of the device as used by a person.

This webinar is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) submission requirement (premarket notification) for changes to an existing device and/or software integrated with a device.

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company’s decisions are provided.

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.

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. The flowcharts address changes to:

FDA Labeling
Technology, engineering and performance
Technology, engineering, performance and materials for in vitro diagnostic devices
The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality. Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device.




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