21CFRPart861(uptodateasof10/15/2024)

21CFRPart861(Oct.15,2024)

ProceduresforPerformanceStandardsDevelopment

ThiscontentisfromtheeCFRandisauthoritativebutunofficial.

Title21—FdandDrugs

ChapterI—FdandDrugAdministration,DepartmentofHealthandHumanServices

SubchapterH—MedicalDevices

Part861ProceduresforPerformanceStandardsDevelopment

SubpartAGeneral

§861.1Purposeandscope.

§861.5Statementofpolicy.

§861.7Contentsofstandards.

SubpartBProceduresforPerformanceStandardsDevelopmentandPublication

§861.20Summaryofstandardsdevelopmentprocess.

§861.24Existingstandardasaproposedstandard.

§861.30Developmentofstandards.

§861.34Amendmentorrevocationofastandard.

§861.36Effectivedates.

§861.38Standardsadvisorycommittees.

PART861—PROCEDURESFORPERFORMANCESTANDARDS

DEVELOPMENT

Authority:21U.S.C.351,352,360c,360d,360gg-360ss,371,374;42U.S.C.262,264.

Source:45FR7484,Feb.1,1980,unlessotherwisenoted.

SubpartA—General

§861.1Purposeandscope.

(a)Thispartimplementssection514oftheFederalFood,Drug,andCosmeticAct(theact)withrespectto

theestablishment,amendment,andrevocationofperformancestandardsapplicabletodevicesintended

forhumanuse.

(b)TheFoodandDrugAdministrationmaydeterminethataperformancestandard,asdescribedunder

specialcontrolsforclassIIdevicesin§860.7(b)ofthischapter,isnecessarytoprovidereasonable

assuranceofthesafetyandeffectivenessofthedevice.Performancestandardsmaybeestablishedfor:

(1)AclassIIdevice;

(2)AclassIIIdevicewhich,upontheeffectivedateo