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. The flowcharts address changes to: • Labeling • 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 guidance includes modifications made to correct software defects, provide patches or updates to code, and provide ...