Hitec IṣoogunFDAikẹkọ -FDADefinition tiMedicalDeiwa buburu
Awọn FDADefinition tiMedicalDeiwa buburu
Awọn ẹrọ iṣoogun tọka si awọn ohun elo, awọn ẹrọ, awọn irinṣẹ, ẹrọ, awọn ohun elo, awọn tubes ifibọ, awọn reagents in vitro, tabi awọn nkan miiran ti o ni ibatan ti o pade awọn ipo wọnyi, pẹlu awọn paati, awọn ẹya, tabi awọn ẹya ẹrọ: awọn ti a ṣe akojọ ni gbangba ni gbigba iwe-aṣẹ ti orilẹ-ede Formulary Formulary National tabi United States Pharmacopeia tabi awọn asomọ si awọn meji ti a mẹnuba;Ti pinnu fun lilo ninu ayẹwo ti ẹranko tabi awọn arun eniyan tabi awọn ipo ti ara miiran;Tabi lo fun arowoto, idinku, tabi itọju awọn arun;Ti pinnu lati ni ipa lori iṣẹ tabi eto ti ẹranko tabi ara eniyan, ṣugbọn laisi gbigbekele awọn aati kemikali ninu ẹranko tabi ara eniyan tabi ara lati ṣaṣeyọri idi akọkọ rẹ, ati laisi gbigbekele iṣelọpọ agbara lati ṣaṣeyọri idi akọkọ rẹ.
FDA ká classification ti egbogi awọn ẹrọ
Kilasi I Gbogbogbo Iṣakoso
Iṣakoso gbogbogbo ti Kilasi II + iṣakoso pataki
Ifitonileti Premarket (PMN), 510 (K)
Kilasi III Iṣakoso Gbogbogbo + Ifọwọsi Ọja iṣaaju
Ifọwọsi Premarket (PMA)
Ilana naa ni lati pin awọn ọja ti o da lori ipele ewu wọn.
Lọwọlọwọ FDA ni diẹ sii ju awọn ẹka 1700 ti awọn ẹrọ, pin si awọn agbegbe ohun elo amọja 16.
862 | Kemistri Isẹgun ati Ile-iwosan Toxicology | 878 | Gbogbogbo ati Ṣiṣu abẹ
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864 | Hematology ati Ẹkọ aisan ara | 880 | Ile-iwosan gbogbogbo ati lilo ti ara ẹni |
866 | Imuniloji ati Maikirobaoloji | 882 | Ẹkọ-ara |
868 | Anesthesiology | 884 | Obstetrical ati Gynecological |
870 | Ẹjẹ ọkan | 886 | Ophthalmic |
872 | Ehín | 888 | Orthopedic |
874 | Eti,Imu ati Ọfun | 890 | Oogun ti ara |
876 | Gastroenterology ati Urology | 892 | Radiology |
Akoko ifiweranṣẹ: Kínní-29-2024