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FDA Roundup: June 16, 2023

FDA Roundup: June 16, 2023
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Drug administrationShelf software use in medical devicesOffice of media affairsDocumentation levelOff the shelf software useMedical devicesMedia 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 affairsDrug administrationShelf software use in medical devicesDocumentation levelOff the shelf software useMedical devicesMedia affairsUs food and drug administration

Recent FDA Draft Guidance to Industry Offers Insight on Content of Premarket Submissions for Device Software Functions | Arnall Golden Gregory LLP

Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include.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 specificationPremarket submissions for device software functionsSoftware requirements specificationDrug administrationPremarket submissionsDevice software functionsFederal foodCosmetic actDocumentation levelEnhanced documentationBlood establishment computer systemEnhance documentationBasic documentationSoftware containedMedical devices

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