User manual

97
For Your Safety
2. What is the FDA’s role concerning the safety of tablets?
Underthelaw,theFDAdoesnotreviewthesafetyofradiation-emittingconsumer
productssuchastabletsbeforetheycanbesold,asitdoeswithnewdrugsormedical
devices.However,theagencyhasauthoritytotakeactioniftabletsareshowntoemit
RadioFrequency(RF)energyatalevelthatishazardoustotheuser.Insuchacase,the
FDAcouldrequirethemanufacturersoftabletstonotifyusersofthehealthhazardand
torepair,replace,orrecallthetabletssothatthehazardnolongerexists.
AlthoughtheexistingscientificdatadoesnotjustifyFDAregulatoryactions,theFDAhas
urgedthetabletindustrytotakeanumberofsteps,includingthefollowing:
• SupportneededresearchintopossiblebiologicaleffectsofRFofthetypeemitted
bytablets;
• DesigntabletsinawaythatminimizesanyRFexposuretotheuserthatisnot
necessaryfordevicefunction;and
• Cooperateinprovidingusersoftabletswiththebestpossibleinformationon
possibleeffectsoftabletuseonhumanhealth.
TheFDAbelongstoaninteragencyworkinggroupofthefederalagenciesthathave
responsibilityfordifferentaspectsofRFsafetytoensurecoordinatedeffortsatthe
federallevel.Thefollowingagenciesbelongtothisworkinggroup:
• NationalInstituteforOccupationalSafetyandHealth
• EnvironmentalProtectionAgency
• OccupationalSafetyandHealthAdministration
• NationalTelecommunicationsandInformationAdministration
TheNationalInstitutesofHealthparticipatesinsomeinteragencyworkinggroup
activities,aswell.
TheFDAsharesregulatoryresponsibilitiesfortabletswiththeFederalCommunications
Commission(FCC).AlltabletsthataresoldintheUnitedStatesmustcomplywithFCC
safetyguidelinesthatlimitRFexposure.TheFCCreliesontheFDAandotherhealth
agenciesforsafetyquestionsabouttablets.