MassMassachachuusesettstts InInssttiittuutte of Technole of TechnoloogygyHaHarvarvarrd Md Meedicadicall SScchohoololBrBrigighaham am annddWWoomemenn’’s Hs HoossppitalitalVA BVA Boossttonon HeHealalthcthcaare Sre Syysstteemm22..7782J82J//33.9.961J61J//BEH.45BEH.4511JJ//HST5HST52424JJFEDERAL REGULATORY ISSUES:FEDERAL REGULATORY ISSUES:US Food and Drug AdministrationUS Food and Drug AdministrationMedical Device AmendMedical Device AmendmmenentstsM. SpecM. Specttor,or, PPhh.D..D.2.782 FDA REPORT2.782 FDA REPORT••••••••10% of grade10% of gradeTotal length: 8 pagesTotal length: 8 pages––Includes text, all images and allIncludes text, all images and all referencesreferencesLine spacing: 1.5Line spacing: 1.5Minimum font: 12Minimum font: 12Page 1GOVERNMENT REGULATION OFGOVERNMENT REGULATION OF MEDICAL DEVICESMEDICAL DEVICESUSUSFDAFDACanCanaadadaHealthHealth CanCanaadadaMexicoMexicoHealthHealth Ministry (uses US FDA)Ministry (uses US FDA)EuropeEuropeEuropean UnionEuropean Union ““CE MarkCE Mark””ChinaChinaChinese FDAChinese FDAIndiaIndiaNoneNoneINDIAINDIA••••India dIndia dooes not regulate thes not regulate the sale of medicae sale of medicaldevices.devices.India accepts nIndia accepts noonn--U.SU.S.. FFoodood & Drug& DrugAdministratiAdministrationon--approved as well as nonapproved as well as non--CECE--marked medmarked mediical dcal deevivicesces––hohowever, iwever, inn accordanceaccordance wwiithth U.SU.S. FDA. FDA requirements, U.S. manufactrequirements, U.S. manufacturers mayurers may onlyonlyexport to India and to other countries medicalexport to India and to other countries medicaldevices that have been approved either by thedevices that have been approved either by theUS FDAUS FDAwwwwww..ita.ita.doc.doc.gov/td/mdegov/td/mdequip/indiarquip/indiareeggs.s.htmlhtmlPage 2US FDA ORGANIZATIONUS FDA ORGANIZATIONCenter forCenter for BiologicsBiologicsEvaluation and Research (CBER)Evaluation and Research (CBER) Center forCenter for DevicesDevicesand Radiological Hand Radiological Heealth (CDRH)alth (CDRH) Center forCenter for DrugDrugEvaluation and Research (CDER)Evaluation and Research (CDER) Center for Food SafetyCenter for Food Safety and Applied Nutritionand Applied Nutrition (CFS(CFSAN)AN)Center for VeterinaryCenter for Veterinary Medicine (CVM)Medicine (CVM) National Center for Toxicological Research (NCTR)National Center for Toxicological Research (NCTR)Office of tOffice of thhe Coe Commmmiissioner (OC)ssioner (OC)Office of Regulatory Affairs (ORA)Office of Regulatory Affairs (ORA)Which center to revWhich center to reviewiew your application?your application?FDAFDACenter for Devices andCenter for Devices and RadiologicRadiologial Healthcal Healthhttp://http://www.fda.gov/cdrwww.fda.gov/cdrh/index.htmlh/index.htmlPage 3FDA APPROVAL PROCESSFDA APPROVAL PROCESSI.I.GeneralGeneralControlsControlsII.II.SpecialSpecialControlsControlsIII.III.PremarketPremarketApproval (PMA)Approval (PMA)ClassificClassificaation of Product as I, II, or IIItion of Product as I, II, or IIIGMGMPPGGoodoodMMaanufnuf..PracticePracticeTE productsTE productsFDA APPROVAL PROCESSFDA APPROVAL PROCESSI.I.GeneralGeneralControlsControlsII.II.SpecialSpecialControlsControlsIII.III.PremarketPremarketApproval (PMA)Approval (PMA)No approval ofNo approval of FDA prior toFDA prior to selling theselling the product.product.ClassificClassificaation of Product as I, II, or IIItion of Product as I, II, or IIIGMGMPPGGoodoodMMaanufnuf..PracticePracticeTE productsTE productsPage 4FDA APPROVAL PROCESSFDA APPROVAL PROCESSI.I.GeneralGeneralControlsControlsII.II.SpecialSpecialControlsControlsIII.III.PremarketPremarketApproval (PMA)Approval (PMA)EquiEquivalvalentent ttoo MarkMarketeteded Device?Device?;;PremaPremarrketketNotificationNotificationNo approval ofNo approval of FDA prior toFDA prior to selling theselling the product.product.ClassificClassificaation of Product as I, II, or IIItion of Product as I, II, or III510 (k510 (k))GMGMPPGGoodoodMMaanufnuf..PracticePracticeTE productsTE productsFDA APPROVAL PROCESSFDA APPROVAL PROCESSI.I.GeneralGeneralControlsControlsII.II.SpecialSpecialControlsControlsIII.III.PremarketPremarketApproval (PMA)Approval (PMA)EquiEquivalvalentent ttoo MarkMarketeteded Device?Device?;;PremaPremarrketketNotificationNotificationNo approval ofNo approval of FDA prior toFDA prior to selling theselling the product.product.ClassificClassificaation of Product as I, II, or IIItion of Product as I, II, or III510 (k510 (k))Analysis of compositionAnalysis of composition and properties, andand properties, and in vitroin vitroandand in vivoin vivostudiesstudiesGMGMPPGGoodoodMMaanufnuf..PracticePracticeTE productsTE productsGGoodood LLaabbPractPract.. GLPGLPPage 5••••FDA APPROVAL PROCESSFDA APPROVAL PROCESSI.I.GeneralGeneralControlsControlsII.II.SpecialSpecialControlsControlsIII.III.PremarketPremarketApproval (PMA)Approval (PMA)Human TrialHuman TrialInvestigationalInvestigational DeviceDevice ExemptionExemptionEquiEquivalvalentent ttoo MarkMarketeteded Device?Device?;;PremaPremarrketketNotificationNotificationNo approval ofNo approval of FDA prior toFDA prior to selling theselling the product.product.ClassificClassificaation of Product as I, II, or IIItion of Product as I, II, or IIIPMAPMA510 (k510 (k))Analysis of compositionAnalysis of composition and properties, andand properties, and in vitroin vitroandand in vivoin vivostudiesstudiesIDEIDEGMGMPPGGoodoodMMaanufnuf..PracticePracticeTE productsTE productsGGoodood LLaabbPractPract.. GLPGLPFDA HistoryFDA Historyhttphttp://www.fd://www.fda.gov/a.gov/oc/oc/ooppaacom/fdcom/fda101/slda101/sld017.h017.httmlml• InIn 11906906, Pre, Pressiiddent Theodorent Theodoree RooseRoosevveleltt sisigned into lgned into laaw thew the FFoood anod and Drugd Drugss ActAct. The. The 11906 la906 law's relevaw's relevantnt babackgckgrroouundnd in Ain Ammerica staerica starrttss with cowith collooninialal ffooodod statustatutteses conceconcerrned withned with brebreaadd anand med meat.at.The firThe firsst nt naationaltional law claw caame ime inn18418488 durinduringg thethe MeMexicxicaann WarWar.. IIttbanbannneded thethe imimporporttatiatioonn of adulof adulteratedterateddrdrugsugs,, aa chronic publicchronic public health prhealth probleoblem.m. • In 1937, a pubIn 1937, a publiclic hehealalth disth disaastersterdemdemoonnsstrtrated theated theneedneed for afor a ssttrorongngeerr ffeeddeerarall law.law. SulSulfanifanilamide,lamide,the firthe