Ire nri, ihe ịchọ mma, ọgwụ na ngwaahịa ndị ọzọ na Amazon US ọ bụghị naanị chọrọ nleba anya nke nkwakọ ngwaahịa, njem, ọnụahịa, na ire ahịa, mana ọ chọkwara nkwado sitere na US Food and Drug Administration (FDA). Ngwaahịa ndị e debara aha na FDA nwere ike ịbanye n'ahịa US maka ọrịre iji zere ihe ize ndụ nke ihichapụ.
Nrube isi na mmesi obi ike bụ isi ihe na-eme ka mbupụ na-aga nke ọma, na ịnweta asambodo FDA bụ "paspọtụ" ịbanye n'ahịa US. Yabụ kedu ihe bụ asambodo FDA? Kedu ụdị ngwaahịa achọrọ ka edebanye aha na FDA?
FDA bụ ụlọ ọrụ na-ahụ maka gọọmentị etiti US maka ịhụ na nchekwa, ịdị mma na nnabata nke nri, ọgwụ, ngwaọrụ ahụike na ngwaahịa ndị ọzọ metụtara ya. Edemede a ga-ewebata mkpa nke asambodo FDA, nhazi ọkwa, usoro asambodo, yana ihe achọrọ maka itinye akwụkwọ maka asambodo. Site na ịnweta asambodo FDA, ụlọ ọrụ nwere ike ibuga ntụkwasị obi na ịdịmma ngwaahịa na nchekwa nye ndị ahịa wee gbasaa ahịa ha.
Mkpa nke asambodo FDA
Asambodo FDA bụ otu n'ime isi ihe maka ọtụtụ ụlọ ọrụ iji nweta ihe ịga nke ọma n'ahịa US. Inweta asambodo FDA pụtara na ngwaahịa ahụ na-emezu ụkpụrụ siri ike yana ihe FDA chọrọ, yana ogo dị elu, nchekwa na nnabata. Maka ndị na-azụ ahịa, asambodo FDA bụ nkwa dị mkpa maka ịdị mma na nchekwa ngwaahịa, na-enyere ha aka ime mkpebi ịzụrụ ihe ọmụma. Maka achụmnta ego, ịnweta asambodo FDA nwere ike ịkwalite aha ika, welie ntụkwasị obi nke ndị ahịa, yana nyere ngwaahịa aka ịpụta n'ahịa na-asọmpi siri ike.
Nnwale FDA
2. Nhazi nke FDA asambodo
Asambodo FDA na-ekpuchi ọtụtụ ụdị ngwaahịa, ọkachasị gụnyere nri, ọgwụ, ngwaọrụ ahụike, ihe ndị dị ndụ, na ngwaahịa radieshon. FDA ewepụtala ụkpụrụ na usoro asambodo kwekọrọ maka ụdị ngwaahịa dị iche iche. Asambodo nri gụnyere ndebanye aha ụlọ ọrụ mmepụta nri, nnabata nke mgbakwunye nri, yana nnabata nke akara nri. Asambodo ọgwụ na-ekpuchi ule ụlọ ọgwụ na nkwenye nke ọgwụ ọhụrụ, asambodo nha anya nke ọgwụ jeneriki, yana mmepụta na ire ọgwụ. Asambodo ngwaọrụ ahụike gụnyere nhazi nke ngwaọrụ ahụike, 510 (k) ọkwa ahịa tupu ahịa, yana ngwa PMA (ịkwado tupu). Asambodo ngwaahịa dị ndụ gụnyere nnabata na ndebanye aha ọgwụ mgbochi ọrịa, ngwaahịa ọbara na ngwaahịa ọgwụgwọ mkpụrụ ndụ ihe nketa. Asambodo ngwaahịa radieshon na-ekpuchi asambodo nchekwa maka akụrụngwa ahụike, ọgwụ redio ọgwụ na ngwaahịa eletrọnịkị.
3. Kedu ngwaahịa chọrọ asambodo FDA?
3.1 Nnwale FDA na asambodo nke ihe nkwakọ nri
3.2 Nnwale FDA na asambodo ngwaahịa seramiiki iko
3.3 Nnwale FDA na asambodo nke ngwaahịa rọba nri nri
3.4 Nri: gụnyere nri edozichara, nri ekpokọtara, nri oyi kpọnwụrụ, wdg
3.5 Ngwa ahụike: ihe mkpuchi na ihe nchekwa, wdg
3.6 Ọgwụ: Ọgwụ ndenye na ọgwụ ndị na-ere ahịa, wdg
3.7 Ihe mgbakwunye nri, ihe mgbakwunye nri, wdg
3.8 Ihe ọṅụṅụ
3.9 Ihe ndị metụtara nri
3.10 FDA ule na asambodo nke mkpuchi ngwaahịa
3.11 Plumbing Hardware Ngwaahịa FDA Nnwale na Asambodo
3.12 Nnwale FDA na asambodo nke ngwaahịa resin roba
3.13 Nnwale na asambodo FDA
3.14 Nnwale FDA na asambodo nke mgbakwunye kemịkalụ
3.15 Laser Radiation Ngwaahịa
3.16 ịchọ mma: ihe mgbakwunye agba, moisturizers anụ ahụ, na ihe nhicha, wdg.
3.17 Ngwaahịa anụmanụ: ọgwụ anụmanụ, nri anụ ụlọ, wdg
3.18 ngwaahịa ụtaba
Ụlọ nyocha BTF, ụlọ ọrụ anyị nwere ụlọ nyocha ndakọrịta electromagnetic, ụkpụrụ nchekwa ụlọ nyocha, ụlọ nyocha redio ikuku ikuku, ụlọ nyocha batrị, ụlọ nyocha kemịkalụ, SAR Laboratory, HAC Laboratory, wdg. Anyị enwetala iru eru na ikike dị ka CMA, CNAS, CPSC, A2LA. VCCI, wdg Anyị ụlọ ọrụ nwere ahụmahụ na ọkachamara teknuzu engineering otu, nke nwere ike inyere ụlọ ọrụ dozie nsogbu ahụ. Ọ bụrụ na ị nwere mkpa ule na asambodo dị mkpa, ị nwere ike ịkpọtụrụ ndị ọrụ nnwale ozugbo iji nweta nkwuputa ọnụ ahịa na ozi okirikiri!
Ndebanye aha FDA Medical
Oge nzipu: Ọgọst-14-2024
