Ukuqonda Amatyesi Kwisixhobo Sezokwelapha Esiphandayo

Isixhobo sokuphanda sibhekisela kolunye uhlobo oluyingozi lwemveliso ephazamisayo kuba amaxhoba asoloko exhomekeke kwizigulana ezisengozini njengeempompo zeinsulin, abachaphazeli besantya, abakhuphi-moya, abakhupheli-moya, kunye nenkqubo yeziyobisi ukuze aqhubeke. Utshintsho olunye ngeqhinga lungakhokelela ekusebenziseni kakhulu, ukuphazanyiswa kombane, ukuhlaselwa, ukungaphumeleli kwesixhobo, okanye ukufa. Xa amaziko alawulayo athe arhane nomthetho arhanela ukuphazamisa ukuphazamisana, kufuneka akhawuleze aqokelele ubungqina aze aphelise umonakalo ongakumbi. Kodwa iSine soMbende seSinyuko sijonge amandla karhulumente, sifuna ukuphenguluka nokuxhwala okusengqiqweni, okuxhaphazekileyo okukhutshwe ngesizathu esifanelekileyo. Ukukhusela impilo kawonke ngemiqatha ye-ogropu yemithetho esetyenziswa ngobuchule xa kuthenjiswa ngezixhobo zezo zezamayeza.

Umthetho womhlaba unzima ngakumbi ngenxa yokuba izixhobo zezamayeza ziphantsi kwemithetho ebekwe ngurhulumente kunye norhulumente. Ukuchaphazeleka kungaphazamisa intlawulo yesizwe , iDiski, kunye neCosmetic Act (FD&C Act) (Umthetho we-FLT) , othintela ukugqwethwa okanye ukuphambaniswa kwezixhobo, kunye nemithetho yezolwaphulo-mthetho, kunye nemithetho yezolwaphulo-mthetho enjenge-18.S.C. . 766666 (ihamba ngeemveliso zabathengi) kunye ne-18.C.[41] (inkohliso, ukuba ingumthetho edla ngokudityaniswa kwemiqathango). Ukuba uphando lweziko lwezixhobo apho isakhiwo sokwenziwa ngekhompyutha eguqulwe ngabomkhwali okanye isixhobo somntu ngamnye, kufuneka alungiswe kwisixhobo sikarhulumente, kwaye afumane i-overtmodural, i-od projective, i-od prorivementment, i-o-mo-rective, i-rect

Ukusetyenziswa Kwasemthethweni Kweemfuno Ezisihlaseleyo

ISinyuselo sesine soMgaqo-siseko waseUnited States sivakalisa ukuba “ilungelo labantu lokukhuselwa kubantu babo, izindlu, amaphepha, kunye neziphumo, ngokuchasene nokuphengulula okungekho ngqiqweni nokuxhuzula, aliyi kuphulwa, kwaye akukho namnye umnqolobi oya kukhupha, kodwa ngokunokwenzeka, oxhaswa ngu-Oath okanye isiqinisekiso, kwaye ichaza ngokukhethekileyo indawo yokuphehlwa, kwaye abantu okanye izinto ezithinjwayo.” Eli lungiselelo limisela umthetho ongagqibekanga: ukuphengulula ngaphandle kwenkqubo yokugweba libukhali ngaphandle kokuba baphaze kwiimeko ezingaziwayo. Kwisixhobo sonyango esiguqula izinto, abaphandayo bamele banikele ubungqina obuqhelekileyo ukuba bangene kumgwebi ongo-jaji-calanti kwaye bafumane isiqinisekiso ngaphambi kokuba bengene eofisini, okanye befune izibonelelo zezixhobo zokurhweba, okanye besebenzisa iingxelo.

Umba ofanelekileyo ngunobangela wesiseko semfuneko yemvume. Ukuseka isizathu esilindelekileyo, abaphengululi kufuneka babonise ukuba kunokwenzeka ukuba ulwaphulo-mthetho lungagcinwanga kwindawo ethile okanye bubungqina bolwaphulo-mthetho luza kufunyanwa kwindawo ukuze luphengululwe. Ekuphanyeni, oku kudla ngokufuna ukubonisa ukuba ulwaphulo-mthetho luye lwenzeka ngabom okanye lutshintshwa okanye lupheliswe ngaphandle kogunyaziso. Ubungqina obunxulumene nokuba ulwaphulo-mthetho lubekwe kwindawo ethile. Iinkundla zivavanya ngokunokwenzeka unobangela osekelwe kwimeko epheleleyo, uqwalasela izibakala noluvo olusengqiqweni oluvela kwimithombo enje ngeengxelo zengqina iliso, iinyawo, uvavanyo lwezibonelelo, umhlazonolwazi lwezingcingo, iimpetho zokufunxa, okanye ukurhoxava. Umbathiso oluxhasa isiqinisekiso kufuneka luqulathe ulwazi olune nengxelo oluzinyolekileyo lokuzinyolwayo; uqikelelo olungenatyala; ubalo olungenatyala.

Unobangela Ofanelekileyo Kwizinto Ezisetyenziswa Ezamayezani

Ukumisa unobangela olindelekileyo wokuguqula kusoloko kufuna ulwazi olukhethekileyo malunga nendlela amacebo ezamayeza asebenza ngayo nendlela angatshintshwa ngayo. Umzekelo, ukuba umatshini wedialysis awusebenzi kakuhle kwaye umguli uyafa, abaphengululi bangafuna ugqirha ochaza ukuba i-software yomatshini yayibhalwe ngokukhululekileyo okanye i-hardware yayo yonakele emzimbeni. I-affidavit kufuneka ichaze icebo, uhlobo lwento erhanelwayo, nayiphi na imbali yeziganeko ezifanayo, nendlela edityaniswa ngayo nokrokrethiso okanye indawo. Kwiimeko apho kukrokrethwa khona iprojethi ekroliweyo, inokubangela ukuba kubekho ulawulo olunekileyo olubonisa umlinganiselo weziphumo eziphazamisayo kwimveliso eqhelekileyo, okanye ngaphakathi kwiingxelo zokuba abasebenzi bakhuphe iprotococration.

Imfuneko ye-nexus ibaluleke kakhulu ekuphandeni kweekhompyutha, ii-cells, okanye ii-akhawunti zamafu. Amacebo ezonyango axhomekeke kwi-software kunye nokunxibelelana ngeminxeba, okuthetha ukuphamba kungabandakanya utshintsho lwamanani. Ukuphengulula ikhompyutha erhanelekayo ukuze kubonwe ukuba iyaphazanyiswa, abaphengululi kufuneka babonise ukuba isixhobo sinokuba siqulethe ubungqina obunjalo, umzekelo, kuba abarhanelwayo babenofikelelo kwizixhobo zekhompyutha kwaye bathumele ugcino-data olukrokrezayo kumncedisi okude. Iinkundla ziye zakholelwa ukuba isiqinisekiso sokuphendla sobu manani kufuneka siphendulwe ngokwaneleyo ukuba sifanele siphephe ukuba siphawule jikelele, nto leyo ithetha ukuba i-ffidat, iintlobo zobungqina be-elektrogen (g., ukulungiswa kosasazo, unxibelelwano, i-software, i-software, i-software, ukuguqula-data-data, i-data-data-data, i-data.

Ukufumana Imali: IAffidavit neNjongo yezeeJaji

Ukuqinisekisa isiqinisekiso kuqala ngomphengululi ofunyanisiweyo ofake isalathisi esingumqondiso ochaza izibakala ezimiselwe unobangela onokwenzeka. I-affidavit mayisayinwe phantsi kwesifungo kwaye inikwe imantswana yesizwe okanye ijaji yesizwe. Ijaji ihlola i-affidavit kulwanela ulwaneliseko olusemthethweni kwaye igqibe ukuba i-application ikhona na unobangela. Ukuba umgwebi ugunyazisa umthetho ukukhangela indawo echaziwe nokuthatha izinto ezikhankanyiweyo. Kwisixhobo sonyango sokuguqula iimeko, isiqinisekiso kufuneka sichaze ngokucacileyo, naziphi na iirekhodi ezinxulumene nogcino-data, kunye nezixhobo okanye izixhobo ezisetyenziswayo ekuphakaleni iprojekthi.

Ngenxa yokuba izixhobo zezamayeza zilawulwa kakhulu, imiyalelo ejoliswe kwisakhiwo sokwenza kufuneka ivumelane nayo nayiphi na imiqathango ethintelayo. Umzekelo, uMthetho weFD&C unika abaphengululi beFDA igunya lokuhlola [[FDA:0] iinspect[ iirekhodi ezithile kunye nezibonelelo ezingenaluqinisekiso phantsi kwemiqathango elinganiselweyo (iiizinto ezingaphantsi), kodwa imvume yokuphengulula kwezaphuli-mthetho zisetyenziswa xa uphazamiso lungafihliwa. Ukwenziwa kwengxelo phakathi kwamagosa ase-FDA kunye nabatshutshisi be-RGB kuqhele ukuqinisekisa ukuba isicelo solwazi olunezokuqukwayo ukuze kuhlale kukhuselwe uvavanyo olukhoyo.

Ukuba imvume ikhutshwa ngokungafanelekanga (ngokomzekelo, ukuba abaphathi bagqithise umlinganiselo wokukhangela okanye abasilele ukunkqonkqoza nokuvakalisa ubukho babo (h'ubuphi ubungqina obufunyenweyo bungacinywa phantsi komthetho osusiweyo. Kwimeko zokuguqula apho ucinezeleko lunokutshabalalisa ubuchule bokuqinisekisa intelekelelo okanye ukuxilonga, ingqalelo elula ukuqinisekisa iimfuno ezibalulekileyo. Iinkundla zibugqumile ubungqina kwiimeko zokuyila imveliso xa i-affidavits zixhomekeke kulwazi oluqinileyo, lungenayo, okanye zingaphumeleli ukuseka uqhagamshelwano phakathi kwesongelo nendawo ekhangelwayo.

Abahlukileyo Kwimfuneko Engummangaliso

Nangona ireyithingi yemvume ingqongqo, izihlandlo eziliqela ezimiselwe kakuhle ezivumela uphengululo olungenasiqinisekiso kunye nokuxhuzula kwisixhobo sokuphanda sezamayeza. Ezi zinxaxhi zilula ukuqondwa kwaye kufuneka zigwetywe zizinto ezingxamisekileyo okanye ezinye iimeko ezinyanzelisayo. Ezininzi ezinokubizwa zezinye iimeko ezingaqhelekanga, imvume, imbono ecacileyo, kunye nophengululo lolawulo kumashishini alawulwa kakhulu.

Iimeko Ezimandundu

Iimeko ezichaphazelekayo zivumela amagosa ukuba enze uphando olungenasiqinisekiso ukuba kukho isisongelo esikhawulezileyo ebomini, umngcipheko wokutshatyalaliswa kobungqina, okanye mhlawumbi ukrokrelwa uya kubaleka ngaphambi kokuba imvume ifumaneke. Kwisixhobo sonyango sokuguqula iimeko, kusoloko kuvela ngenxa yokuba amacebo atshintshiweyo ayaqhubeka esetyenziswa kwizigulana. Umzekelo, ukuba abaphengululi bayazi ukuba isibhedlele sifumene ingqokelela yeempompo ze-injini ezimpompo ezinokuthi zangcoliswa ngabom, basenokufuna ukungena kwigumbi lokunikezela impompompo nokukhusela umonakalo osisigulayo. Ngokunjalo, ukuba ukrokrexo luyaqhubeka kwinkqubo yokulungisa amacebo kwaye lunokutshabalalisa ubungqina ngokususa iiproglagi okanye amanani, abaphathi-opatrogi, bangangena phantsi kwe-projectivessss.

Iinkundla zifuna ukuba urhulumente abonise isiseko esinenjongo sokukholelwa ukuba isantya sikho ngexesha lokufuna. Uxinzelelwano malunga nengozi alwanele; kufuneka kubekho izibakala ezicacileyo ezibonisa ukuba ukulinda imvume ethile kungaphumela ekonakaleni okanye ekulahlekelweni kobungqina. Umzekelo, ukuba umvuli-mkhalazi uchaza ukuba umqeshi ongonwabanga uphazamisana nabenzi besantya ngoku kumgqeba kwaye isakhiwo sitshixiwe, abaphathi-majoni banokugqiba ngokusengqiqweni ukuba ukungena okungena okungenayo kuyathetheleleka ukuyeka ukuphazamisa. Emva kokuphendla, urhulumente uthwala umthwalo wokungqina ukuba ubuchule bunyanisile kwaye hayi iqhatho nje yokunga kwesiqinisekiso.

Umququzeleli

Ukuba umnini okanye umntu ogunyazisiweyo unika imvume ngokuzithandela, abaphathi basesibhedlela bangaphendla ngaphandle kwemvume. Kuphando olugunyaziswayo, maxa wambi imvume ifunyanwa kubaphathi bezakhiwo okanye abanikazi bezixhobo abangakrokrelekanga. Noko ke, umntu ovumayo kufuneka abe negunya lokwenene okanye elicacileyo kwindawo ukuze ahlolwe. Umlawuli wesibhedlele angavuma ukuphengululwa kwendawo yokugcina jikelele, kodwa hayi kwiofisi evaliweyo esetyenziswa ngugqirha othile onegunya. Ukuvalwa kwe-ofisi kusenokurhoxiswa nangaliphi na ixesha, kwaye abaphathi-majoni abakwazi ukunyanzela ukuphembelela ngemisongelo okanye inkohliso. Kwizinto eziphezulu eziphazamisayo, ukufumana isivumelwano kummeli wenkampani esebenzelayo kuyacetyiswa ukuba aphephe iimpikiswano zamva.

Umboniso ocacileyo

Ukuba umphathi-mikhosi ukho ngokusemthethweni kwindawo (njenge-pursuant kwisiqinisekiso, imvume, okanye imvume) kwaye aphawule into echongiweyo ngoko nangoko, loo nto ingabanjwa ngaphandle kwesiqinisekiso phantsi kwemboniselo ecacileyo. Umzekelo, xa uphengululo lomgangatho ophantsi komenzi phantsi kwesiqinisekiso esisemthethweni sokuphazamisa iimpompo eziphisayo, umphathi-mikhosi wekhompyutha ujonga ikhomputha etshintshiweyo yekhowudi ye-software efanayo. Igosavereta angathabatha ikhompyutha okanye athathe isikrini ngenxa yokuba indalo yekhowudi ecacileyo icacile ngokukhawuleza. Noko ke, umphathi-ofisi kufuneka afumane ubungqina obusemthethweni obungaqondakaliyo.

Uphando Lolawulo Kwimizi - mveliso Elawulwa Ngokulula

Abenzi bezixhobo zezokwelapha basebenza kushishino oluphenjelelwayo. Phantsi koMthetho weFD&C, abaphandi beFDA bangangena baze bahlole nawuphi na umzi - mveliso, indawo yokugcina impahla, okanye indawo apho amacebo enziwe khona, alungelelaniswa, okanye abanjwe, phantsi kwemiqathango ethile. [ Oku kuphengululo olungagqibekanga kuphandwa kuphando olusemthethweni[[] akufuni siqinisekiso ukuba ziqhutywa njengenxalenye yendlela yokuhlola okuqhelekileyo. [2] Inkundla ephakamileyo iyazi ixesha elide ukuba amashishini kwimizi yolawulo elawulwa kakhulu ajongekelwe phantsi kakhulu, kwaye ivulekele i-'''''''' i-'''''''''' i-'i-'colon'' xa kuvulwe uvavanyo olupheleleyo lwembali olupheleleyo. [bl.'i-FT] [1970] kunye no-1970] [i-B] imvume yovavanyo olupheleleyo lweziko yoncedo lweziko yoncedo olupheleleyo lwezikolongo lo

Abenzi bezixhobo zezamayeza, abalawuli beFDA bokuhlolwa. Ngokungafaniyo novavanyo lolwaphulo-mthetho ngaphantsi kwama-21 e-U.S.C. . 374 banika abahloli ilungelo lokungena kwizixhobo ngexesha leshishini eliqhelekileyo, izixhobo, zigqitywe kwaye zingagqitywanga izinto zokuyila, izikhongozeli, kunye nokuzichaza, kwaye bathathe amasampuli. Umhloli kufuneka anike isiqinisekiso esifanelekileyo kunye nesaziso sokuhlola. Ngokungafaniyo novavanyo lolwaphulo-mthetho, ukuhlolwa kolwaphulo-mthetho, ukuphengulula akufuni sizathu esilindelekileyo sokwaphula umthetho. [FL: 0] Ukuphengulula i-mthetho okufanelekileyo kumele kuqinisekise ukuba ukwenziwa kwangoku, ukusetyenziswa kakuhle (CGMP) kuyimfuneko (CFRRRRRRRRRR 820) kunye nokungakhangelwa kwemithetho yezo yokuzinziwa kwetyala ngenxa yokunga. Kodwa, ukupheliswa kweminye i-Applity, i-Applity, i-op, i-octivess.

Ukhathalelo olukhethekileyo lwezixhobo zonyango ze-elektroniki ne-Software esekelwe kwi-octal

Amacebo angoku ezamayeza anxulumene ngokukhulayo, aqulethe i-microprocessors, i-software, kunye namandla onxibelelwano ngocingo. Ukusebenzisa i-Tamper kungabandakanya ukuphakamisa ikhowudi enetyala lesixhobo, ukutshintsha izicwangciso zezixhobo ngomnatha, okanye ukuphazamisana nokudluliselwa kogcino-lwazi. Ezi milinganiso zamanani ziphakamisa imibuzo engaqhelekanga yeSine Solawulo-Mpatho-Mda malunga noko kukuthi kuqukwa kwento ekhoyo kwiselfowuni. Ukujijaly v.[FLT][FLT] [2014] [2014] [iiiN, iNkumbuso ePhakamileyo ifuna ukuba amapolisa afumane isiqinisekiso sokuhlola iseli yeseli ebanjiswe kwimeko ekhoyo, ngenxa yolwazi oluninzi olukhoyo kwizixhobo ezinjalo. Ngokuqinisekisa ukuba kungene i-HPA, okanye ngokusetyenziswa kwe-SCPGPGPGPGP, kufuneka agunyazwe ligunyazwe ligunya elisemthethweni lonyango lonyango lonyango lonyango lonyango lonyango lonyango lonyango, lwe-H

Ingxelo enxulumene nento leyo kukuba ngaba ukufikelela kwi-software yesixhobo sezamayeza ngaphandle kokuvula ngokoqobo isixhobo kuyila uphendlo lwesine soMbetho. Iinkundla azikawuphenduli ngokuqiniseki lo mbuzo, kodwa imigaqo jikelele icebisa ukuba ukufikelela ulwazi olugcinwe okanye oludluliselwe sisixhobo esilindele ukuba umsebenzisi aqhubeke esesemngciphekweni wokufuna isiqinisekiso. Umzekelo, ukuvala unxibelelwano phakathi kwe-cardioverter-debrillator kunye nenkqubo kusenokuthotyelwa kwi-PUmthetho we-PUNICERT ngokunjalo. Abaxhasi kufuneka badibanise nabatshutshisi-mali kunye nokufumana isiqinisekiso sokufumana imvume engqalileyo yokufumana ulwazi kwisixhobo sombane, kuquka nezixhobo zokuhlola ii-adioperator.

Uxanduva lwabasebenzi bezixhobo zezamayeza nabaLawuli-mali

Abenzi bezixhobo zezokwelapha banembopheleleko esemthethweni nefanelekileyo yokuyila izixhobo ezixhathisa ukuphanda nokusebenzisana nophando xa kurhanelwa. Isikhokelo se-FDA se-Cybersecurity Isikhokelo (Ukonakalisa 524B ye-FD&C) ikhuthaza abenzi ukuba basebenzise indlela esekelwe kumngcipheko wokufumana ukhuseleko lwe-intanethi, kuquka amanyathelo okufumana nokuphanda. Abacebisi kufuneka basebenzise iimpawu ezifana ne-projekthi e-info-fictive sletyle, ukuthembeka kwe-software, kunye ne-unicateogs ezibhaliweyo okungagunyazisiweyo. Kwisiganeko sophando, abakhi-machingi bamele baqonde ukuba abanakuchasamkelwa ngokusemthethweni okanye uphando olusemthethweni. Obclactal anokukhokelisa ukuphendla okungelela kwityala okungelelwe phantsi kolawulo lwe-18.C.

Abanikezi bonyango abasebenzisa izixhobo zonyango nabo kufuneka babe nemigaqo ecacileyo yokuxela ukuba kurhanelwa ukuphakanyiswa komthetho kunye namagunya omthetho. Phantsi koMthetho weSebe leSebe leMicimbi (SMDA), iziganeko ezithile ezingezizo ezibandakanya izixhobo zonyango kufuneka zichazwe kwiFDA. Ukuxhobisa okunokubangela ukufa okanye umonakalo onzulu yisiganeko esinokuxelwa. Abanikezi kufuneka bagcine bonke ubungqina obufanelekileyo, kuquka isixhobo ngokwaso, nasiphi na isigqeba, kunye nezitishi, de kufike ukunyanzelelwa komthetho. Bamele balubeke ulwano lwesixhobo ukuze bathintele ukungcoliswa kobungqina.

Abenzi kufuneka baqonde ukuba ukusebenzisana nophando akulichasi ilungelo lenkampani lokucel'ucelomngeni lokufuna uphando olungekho mthethweni. Ukuba uphando olungenasiqinisekiso luye luphele ngaphandle kwemvume okanye ukunyanzeleka, umenzi angathatha uhambo lokucinezela ubungqina aze afune umonakalo wamakhaya phantsi kwama-42 U.S.C. ngo1934 ngenxa yokwaphulwa kwamalungelo omgaqo-siseko. Ngaloo ndlela, abenzi mabafake isiluleko esisemthethweni kwasekuqaleni nakokuphi na ukuqinisekisa ukuba amalungelo abo akhuselwa ngokufanelekileyo ngoxa besasebenzisana.

Isiphumo: Ukulungelelaniswa koKhuseleko loLuntu namalungelo oMgaqo-siseko

Iimfuno eziqinileyo zesixhobo sonyango sokuguqula amatyala zibonisa ukulungelelana okunamandla phakathi komdla karhulumente wokukhusela izigulana kwimveliso eyingozi kunye nelungelo lomntu lokukhululeka ekungeneleni korhulumente okungekho ngqiqweni. Ngoxa uLawulo lwesine lufuna isiqinisekiso esixhaswa ngokunokwenzeka, utshintsho olungxamisekileyo lweziganeko lusoloko lubangela ukuba kubekho iimeko ezibonisa ukuba intsabelo ekhawulezileyo, engenasizathu ukukhusela umonakalo ongakumbi. Umgaqo wezixhobo zonyango uvumela ukuvunywa kwezixhobo zolawulo ezingenakusetyenziswa, kodwa ezi kufuneka zihlale kwimida yenjongo yokulungisa izinto kwaye zingabi yindawo yokulungisa imoto ukuze kuphendulwe uphando lolwaphulo-mthetho.

Ukunyanzeliswa komthetho kunye nabatshutshisi, impumelelo ixhomekeke ekulungiseleleni ngenyameko: ukwenza ii-affidavits ezichaza ngokucokisekileyo isixhobo kunye nokuphakanyiswa, ukwazi ixesha lokufuna isiqinisekiso, ixesha lokucela imvume, kunye nokubhekiselela kwimfuneko ekhethekileyo yobungqina bemichiza. Kubenzi nabasebenzi abanyamekela impilo, ukuqonda ezi mfuneko ziyimfuneko kunceda intsebenziswano esemthethweni zikwazi ukugcina ubungqina ngaphandle kokunikezela ngokhuseleko lomgaqo-siseko. Ekugqibeleni, uphando oluneyo olusemthethweni oluchane ityala elingakhathazi nje kuphela kodwa lugcina ukuthemba kwabantu bonke kwingqibelelo yezixhobo zonyango kunye nenkqubo yokusesikweni.

[[UMTL_HAWU] Izibonelelo:[[UMKCU]

  • [[UMTL:0] IsiHlalisi-somhlaba se-Four - Cornell Legin Information Institute[FLT: 1]
  • FDA: Ukuxela Iziganeko Ezibi Zezixhobo Zonyango
  • FDA Isikhokelo sokuKhuphela Izixhobo zamayeza
  • [[UMTL:0]U.S. ISebe leJaji – iZibonelelo zoHlaziyo zesine [[FLT: 1]