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ContainsNonbindingRecommendations
Off-The-ShelfSoftwareUsein
MedicalDevices
GuidanceforIndustryand
FoodandDrugAdministrationStaff
DocumentissuedonAugust11,2023.
DocumentoriginallyissuedonSeptember9,1999.
ThisdocumentsupersedesOff-The-ShelfSoftwareUseinMedicalDevices
issuedSeptember27,2019.
Forquestionsaboutthisdocument,contacttheDigitalHealthCenterofExcellencebye-mail
atdigitalhealth@.
U.S.DepartmentofHealthandHumanServices
FoodandDrugAdministration
CenterforDevicesandRadiologicalHealth
ContainsNonbindingRecommendations
Preface
PublicComment
YoumaysubmitelectroniccommentsandsuggestionsatanytimeforAgencyconsiderationto
.SubmitwrittencommentstotheDocketsManagementStaff,Food
andDrugAdministration,5630FishersLane,Room1061,(HFA-305),Rockville,MD20852.
IdentifyallcommentswiththedocketnumberFDA-2019-D-3598.Commentsmaynotbeacted
uponbytheAgencyuntilthedocumentisnextrevisedorupdated.
AdditionalCopies
AdditionalcopiesareavailablefromtheInternet.Youmayalsosendane-mailrequestto
CDRH-Guidance@toreceiveacopyoftheguidance.Pleaseusethedocument
numberGUandcompletetitleoftheguidanceintherequest.
ContainsNonbindingRecommendations
TableofContents
I.Introduction4
II.Scope5
III.OTSSoftwareDocumentationElements6
A.DescriptionofOTSSoftware7
B.RiskAssessmentofOTSSoftware9
C.SoftwareTestingasPartofVerificationandValidation9
D.Assura
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