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FDA Roundup: June 16, 2023

June 16, 2023

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted...

Office Of Media Affairs Drug Administration Shelf Software Use In Medical Devices Documentation Level Off The Shelf Software Use Medical Devices

Source: prnewswire.com

Recent FDA Draft Guidance to Industry Offers Insight on "Content of Premarket Submissions for Device Software Functions" | Arnall Golden Gregory LLP

November 29, 2021

Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include...

Software Design Specification Premarket Submissions For Device Software Functions Software Requirements Specification Drug Administration Premarket Submissions Device Software Functions

Source: jdsupra.com

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FDA Roundup: June 16, 2023

Recent FDA Draft Guidance to Industry Offers Insight on "Content of Premarket Submissions for Device Software Functions" | Arnall Golden Gregory LLP

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