产品召回行业指南.docxVIP

OnFebruary2,2024,FDApublishedthefinalruletoamendtheQualitySystem(QS)regulation

in21CFRpart820(89FR7496,effectiveFebruary2,2026).Therevised21CFRpart820is

nowtitledtheQualityManagementSystemRegulation(QMSR).TheQMSRharmonizesqualitymanagementsystemrequirementsbyincorporatingbyreferencetheinternationalstandard

specificformedicaldevicequalitymanagementsystemssetbytheInternationalOrganizationforStandardization(ISO),ISO13485:2016.TheFDAhasdeterminedthattherequirementsinISO13485are,whentakenintotality,substantiallysimilartotherequirementsoftheQSregulation,providingasimilarlevelofassuranceinafirm’squalitymanagementsystemandabilityto

consistentlymanufacturedevicesthataresafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(FDCAct).

ThisguidancedocumentwasissuedpriortothefinalruleissuedonFebruary2,2024.Whilethisguidancediscussesrecallproceduresandrequirements,manufacturersshouldbeawarethattheQMSRincludesupdatedqualitymanagementsystemrequirementsthatmayimpactrecall-relatedprocessesformedicaldevicesorcombinationproducts.

FDAencouragesmanufacturerstoreviewthecurrentQMSRtoensurecompliancewiththerelevantregulatoryrequirements.

ContainsNonbindingRecommendations

1

ProductRecalls,IncludingRemovals

andCorrections

GuidanceforIndustry

TheFDAisissuingthisguidanceforimmediateimplementationinaccordancewith21CFR

10.115(g)(4)(i).Submitonesetofeitherelectronicorwrittencommentsonthisguidanceatanytime.Submitelectroniccommentsto/.SubmitwrittencommentstotheDocketsManagementStaff,FoodandDrugAdministration,5630FishersLane,Room

1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberFDA-2003-D-0146.

Forquestionsregardingthisguidanceoradditionalcopies,contacttheOfficeofRegulatoryAffairs