FDA's New Draft Guidance on Software and Device Changes and the 510(k)
March 20, 2020 - CA USCompliance4all
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Overview: 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. 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 and performance Materials 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. Event link: https://www.compliance4all.com/webinar/-502920LIVE?channel=drugdiscoveryonline_2020_SEO Contact Info Netzealous LLC, DBA -Compliance4all Email: support@compliance4All.com Phone: +1-800-447-9407 Website: https://www.compliance4all.com/