Kuki Ibyuma Bifunga Amarangi Bikeneye Kwemerwa na FDA? — Isesengura ryimbitse ry'akamaro k'uburyo bwo kwemeza no kugenzura FDA

Intangiriro: Isano Ihishe Hagati ya FDA na Rubber Seals
Iyo tuvuze FDA (Ikigo gishinzwe Ibiribwa n'Imiti muri Amerika), abantu benshi bahita batekereza ku miti, ibiribwa, cyangwa ibikoresho by'ubuvuzi. Ariko, bake ni bo batazi ko n'ibice bito nk'udupfundikizo twa kabutura bigenzurwa na FDA. Agapfundikizo ka kabutura gakoreshwa cyane mu bikoresho by'ubuvuzi, mu mashini zitunganya ibiribwa, mu bikoresho by'imiti, ndetse no mu bikoresho by'indege. Nubwo ari gato, bigira uruhare runini mu gukumira amazi ava mu kirere, kwanduzanya, no kurinda umutekano. Iyo udupfundikizo tutujuje ubuziranenge, dushobora gutuma ibikoresho byangirika, kwanduzanya ibicuruzwa, cyangwa se bikangiza ubuzima. Bityo, kwemerwa na FDA biba "igipimo ngenderwaho cya zahabu" kuri ibyo bicuruzwa. Ariko se kwemerwa na FDA bivuze iki? Wakwemeza ute niba ibicuruzwa byemewe koko? Iyi nkuru izasuzuma ibi bibazo mu buryo burambuye, ikoresheje ingero zifatika zo mu nganda zipfundikizo za kabutura kugira ngo igufashe gusobanukirwa akamaro kabyo.

Byavuzwe na FDA mu buryo busobanutse neza — Gusobanura neza “Byemejwe na FDA mu buryo busobanutse neza?”
Kwemerwa na FDA ni ijambo rikunze kuvugwaho kenshi ariko rikunze kumvikana nabi. Muri make, kwemerwa na FDA bivuze ko ibicuruzwa byakorewe isuzuma rikomeye n’Ikigo gishinzwe ibiribwa n’imiti muri Amerika kugira ngo byemeze ko byujuje ibisabwa mu mutekano, imikorere, n’ubuziranenge ku mikoreshereze yihariye. Ariko, iyi si inzira ikorwa mu ijoro rimwe; ikubiyemo isuzuma rirambuye, gutanga inyandiko, no gukomeza gukurikirana.

Ku birebana n'udupfundikizo twa rubber, icyemezo cya FDA gikunze kuvuga ibikoresho byubahirije amabwiriza ya FDA, nka 21 CFR (Amabwiriza ya Leta) Igice cya 177, kivuga ku bisabwa ku nyongeramusaruro ku biribwa zitaziguye, cyangwa Igice cya 820, kivuga ku mabwiriza y'ubuziranenge ku bikoresho by'ubuvuzi. Niba udupfundikizo twa rubber dukoreshwa ahantu hahurira ibiryo (urugero, udupfundikizo mu bikoresho bitunganya ibiryo) cyangwa ibikoresho by'ubuvuzi (urugero, udupfundikizo mu nsinga cyangwa ibikoresho byo kubaga), bigomba gukorwa mu bikoresho byemewe na FDA kugira ngo bitangiza ibintu byangiza, bitera allergie, cyangwa ngo byanduze ibicuruzwa.

Amahame shingiro yo kwemezwa na FDA akubiyemo:

• Umutekano Mbere na Mbere: Ibikoresho bigomba gutsinda ibizamini by’uburozi kugira ngo byemezwe ko bidasohora imiti yangiza mu gihe byagenwe gukoreshwa. Urugero, ibikoresho bisanzwe bifunga irangi nka silicone cyangwa EPDM bikorerwa ibizamini byo gukuramo irangi kugira ngo bipime ubushyuhe bwabyo butandukanye n’urugero rwa pH.
• Igenzura ry’imikorere: Ibicuruzwa bigomba kuba byizewe mu mikorere, nko gufunga bihangana n’ihindagurika ry’umuvuduko n’ubushyuhe nta gutsindwa. FDA isuzuma amakuru apima kugira ngo irebe ko ikora neza mu bikorwa nyabyo.
• Iyubahirizwa rya sisitemu y’ubuziranenge: Abakora bagomba gukurikiza amabwiriza meza yo gukora (GMP), bakareba ko intambwe yose yo gukora igenzurwa kandi igakurikiranwa. Ku bigo bifunga ibirungo bya kabutura, ibi bivuze kubika inyandiko zirambuye no kugenzura buri gihe kuva ku gushakisha ibikoresho fatizo kugeza ku kohereza ibicuruzwa byarangiye.

Ni ngombwa kumenya ko kwemerwa na FDA atari ikintu kimwe gusa. Biza mu buryo butandukanye:

• Kwemeza Isoko (PMA): Ku bikoresho by’ubuvuzi bifite ibyago byinshi, bisaba amakuru menshi y’ubuvuzi. Ibipfukisho bya kabutike bikoreshwa mu bikoresho bishobora gushyirwamo nk’ibikoresho bifasha mu mugongo bishobora kuba birimo PMA.
• 510 (k) Ihererekanya: Ikoreshwa ku bicuruzwa biri hagati kugeza ku bifite ibyago bike, iyi nzira igerwaho binyuze mu kugaragaza "uburinganire bufatika" n'igikoresho cy'inyongera cyamaze kugurishwa byemewe n'amategeko muri Leta Zunze Ubumwe za Amerika. Ibyuma byinshi bya kabutike bikoreshwa mu bikoresho bisanzwe by'ubuvuzi bikurikiza iyi nzira yo kwemererwa.
• Itangazo ry’uko ibintu bishobora gukwirakwira mu biribwa (FCN): Ku bikoresho bishobora gukwirakwira mu biribwa, aho abakora ibicuruzwa batanga itangazo, kandi niba FDA nta kirego itanze, ibicuruzwa bishobora kugurishwa ku isoko.

Gusobanukirwa izi tandukaniro ni ingenzi ku nganda zikora ibishushanyo mbonera bya kabutura. Ntabwo bifasha amasosiyete kwirinda ingaruka zemewe n'amategeko gusa, ahubwo binabafasha kugaragaza ibyiza byo kwamamaza, nko kuvuga ngo “Ibishushanyo mbonera byacu byubahiriza amahame ya FDA 21 CFR 177” kugira ngo bikurure abakiriya mu nzego z’ubuvuzi cyangwa iz’ibiribwa.

Nigute wagenzura niba ibicuruzwa byemewe na FDA? — Gusubiza uti “Nigute wagenzura niba ibicuruzwa byemewe na FDA?”
Kugenzura niba ibicuruzwa byemewe na FDA ni ikintu gikunze gukenerwa n'abaguzi n'ibigo, ariko inzira ishobora kugorana. FDA ntabwo "yemera" buri gicuruzwa ku giti cyacyo; ahubwo yemera ibikoresho, ibikoresho, cyangwa inzira runaka. Bityo, kugenzura bisaba uburyo bw'intambwe nyinshi. Hasi hari uburyo bufatika, hakoreshejwe imitako ya rubber nk'urugero:

1. Reba amakuru yemewe ya FDA: FDA itanga amakuru menshi kuri interineti, akenshi:
   • Iyandikwa ry'ibikoresho bya FDA n'urutonde rw'ibicuruzwa: Ku bikoresho by'ubuvuzi. Andika izina ry'ikigo cyangwa inomero y'ibicuruzwa kugira ngo urebe uko byiyandikishije. Urugero, niba ibikoresho by'ubuvuzi bikoreshwa mu bikoresho by'ubuvuzi, uwabikoze agomba kuba yanditswe muri FDA kandi afite ibicuruzwa byanditse ku rutonde.
   • Amakuru yerekeye uburyo ibiryo bikoreshwa mu kumenyesha abantu uko bamerewe (FCN) ku biribwa: Ku bijyanye n'ibikoresho bikoreshwa mu kuvura ibiryo. Shakisha ukurikije izina ry'ibikoresho cyangwa uwabikoze kugira ngo urebe niba hari FCN yemewe.
   • Ibikoresho byemewe na FDA (Ikitabo cy'Umuhondo) cyangwa Ibikoresho by'Ubuvuzi: Ibi birushaho kugira akamaro ku miti cyangwa ibikoresho muri rusange aho kuba ibice byabyo. Ku birebana n'ibipfukamunwa, ni byiza gutangirira ku wabikoze.

   Intambwe: Sura urubuga rwa interineti rwa FDA (fda.gov) kandi ukoreshe uburyo bwo gushakisha. Andika amagambo y'ingenzi nka "rubber seals" cyangwa izina ry'ikigo, ariko ibisubizo bishobora kuba bigari. Uburyo bwiza kurushaho ni ukubaza nomero y'icyemezo cya FDA cy'uruganda cyangwa kode y'igicuruzwa.

2. Suzuma Ibirango by'Ibicuruzwa n'Inyandiko: Ibicuruzwa byemewe na FDA bikunze kugaragaza amakuru yerekeye icyemezo ku birango, ku bipfunyika, cyangwa inyandiko za tekiniki. Urugero, ibirango bya kabutike bishobora kuba byanditseho "ibyemewe na FDA" cyangwa "USP Class VI" (Ibipimo ngenderwaho bya US Pharmacopeia Class VI, bikunze gukoreshwa mu bikoresho by'ubuvuzi). Menya ko "ibyemewe na FDA" bishobora gusa kuvuga ko byubahiriza amabwiriza aho kuba ibyemewe ku mugaragaro, bityo rero hakenewe igenzura ryinshi.
3. Vugana n'uwakoze cyangwa usabe Impamyabushobozi: Nk'ubucuruzi, ushobora gusaba uwatanze ibipfundikizo bya rubber icyemezo cyangwa raporo z'ibizamini byemewe na FDA. Ibigo byemewe bizatanga:
   • Icyemezo cy'uko ibintu byujuje amabwiriza ya FDA: Icyemezo cy'uko ibikoresho byujuje amabwiriza ya FDA.
   • Raporo z'ibizamini: Nk'ibizamini byo gukuramo cyangwa ibizamini byo guhuza n'ibinyabuzima (ku bijyanye n'ikoreshwa ry'ubuvuzi) bivuye muri laboratwari z'abandi.
   • Nimero yo kwiyandikisha muri FDA: Niba uruganda rukora ibikoresho by'ubuvuzi muri Amerika, rugomba kwandikisha ikigo cyabo muri FDA.
4. Koresha Ibigo Bitanga Impamyabushobozi ku Banyamigabane Batatu: Hari igihe kwemezwa na FDA byoroherezwa binyuze mu mpamyabushobozi ku banyamigabane Batatu (urugero, NSF International cyangwa UL). Gusuzuma amakuru y’ibi bigo bishobora no gutanga ibimenyetso.
5. Itondere Ingaruka Zisanzwe: Kwemerwa na FDA si ikintu gihoraho; bishobora gukurwaho bitewe n'impinduka mu mategeko cyangwa ingaruka nshya. Bityo, kugenzura buri gihe ni ingenzi. Byongeye kandi, irinde kwitiranya "yemejwe na FDA" na "yanditswe na FDA." Kwiyandikisha bivuze gusa ko sosiyete iri ku rutonde rwa FDA, ariko si ngombwa ko ibicuruzwa byemewe. Ku bijyanye n'ibipfunyika bya rubber, hibandwa ku kwemerwa ku rwego rw'ibikoresho.

Dufate urugero rw'ikigo gifunga ibirungo: Tuvuge ko ikigo cyawe gikora impeta zo gufunga ibikoresho bitunganya ibiribwa. Ushobora kwerekana ishema "Ibicuruzwa byacu biratsinda ibizamini bya FDA 21 CFR 177.2600" kandi ugahuza raporo z'ibizamini ku rubuga rwawe, bikazamura icyizere cy'abakiriya. Hagati aho, iyo wigisha abakiriya, ushobora kubayobora ku buryo bwo kugenzura ku giti cyabo, ibyo bikaba binongera ubwisanzure mu gukorera mu mucyo gusa, ahubwo binashimangira ububasha bw'ikirango.

Ingaruka zo Kwemezwa na FDA ku Nganda z'Ibipfukisho bya Rubber
Nubwo imitako mito, irakenewe cyane mu ikoreshwa ry’ibicuruzwa byo mu rwego rwo hejuru. Kwemerwa na FDA si ikibazo cyo kubahiriza amategeko gusa, ahubwo ni n'ikimenyetso cy'ipiganwa ku isoko. Dore ingaruka zikomeye zabyo:

• Imbogamizi yo kugera ku isoko: Mu nganda nyinshi, nko mu buvuzi cyangwa mu biribwa, ibicuruzwa bidafite uruhushya rwa FDA ntibishobora kwinjira ku isoko rya Amerika. Dukurikije amakuru ya FDA, hejuru ya 70% by'ibikoresho by'ubuvuzi bishingiye ku biti by'umukara, kandi hafi 15% by'ibyanduzwa buri mwaka mu nganda z'ibiribwa bifitanye isano no kwangirika kw'ibiti by'umukara. Kubwibyo, gushora imari mu kwemezwa na FDA bishobora kwirinda isubizwa ry'umukara rihenze n'amakimbirane mu by'amategeko.
• Icyizere n'Itandukaniro ry'Ikirango: Mu gushakisha kuri Google, amagambo y'ingenzi nka "Ibipfuko byemewe na FDA by'amabara y'urubura" yiyongera buri kwezi, bigaragaza ko abaguzi n'ibigo by'ubucuruzi bahangayikishijwe cyane n'umutekano. Mu gukora ibikubiye mu nyigisho (nk'iyi nkuru), ikigo cyawe gishobora gukurura abantu benshi kandi kikanoza urutonde rwa SEO. Google ikunda ibikubiye mu buryo bw'umwimerere kandi bufite amakuru maremare, bityo isesengura ryimbitse ry'amagambo 2000 rishobora gushyirwa mu rutonde.
• Umushinga w’udushya: Amabwiriza ya FDA ashishikariza guhanga udushya mu bikoresho. Urugero, guteza imbere ibikoresho bya kawurute bibungabunga ibidukikije kandi bihuye n’ibinyabuzima bishobora gufungura amasoko mashya, nk’ibikoresho byo kwa muganga byambarwa cyangwa gutunganya ibiryo by’umwimerere.
• Ikiraro cyo kubahiriza amategeko mpuzamahanga: Kwemerwa na FDA bikunze gufatwa nk'ikimenyetso mpuzamahanga, kimwe n'ikimenyetso cya CE cya EU. Ku bashora imari mu mahanga, byoroshya kwinjira mu yandi masoko.

Ariko, hari imbogamizi. Gahunda ya FDA ishobora gutwara igihe kinini kandi ihenze—ishobora kuva mu mezi 6-12 n'amafaranga ibihumbi mirongo y'amadolari mu isuzuma. Ariko ku bigo bifite inshingano, ni ishoramari rifite akamaro. Binyuze mu kugenzura ubuziranenge bw'imbere mu gihugu no kugenzura buri gihe, ushobora koroshya inzira.