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FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding
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Software-detailed-design , Software-architectural-design , Program-for-medical-device-submissions , Guidance-the-agency , Software-architecture-design , Shelf-software-use-in-medical-devices , Premarket-submissions-for-device-software-functions , King-spalding , European-union-medical-devices-regulation , Software-design-specification , Device-software-functions

FDA Roundup: June 16, 2023

FDA Roundup: June 16, 2023
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Drug-administration , Shelf-software-use-in-medical-devices , Office-of-media-affairs , Documentation-level , Off-the-shelf-software-use , Medical-devices , Media-affairs ,

FDA Roundup: 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 , Media-affairs , Us-food-and-drug-administration ,