Mayelana ne-FDA: I-FDA ixwayisa umphakathi kanye nabasebenzi bezempilo ukuthi bangasebenzisi izinsimbi ezingenanaliti ukujova ama-dermal fillers

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Isicaphuna esilandelayo sivela ku-Binita Ashar, MD, Umqondisi Wehhovisi Lokuhlinza Nezisetshenziswa Zokulawula Ukutheleleka Esikhungweni Se-FDA Samadivayisi Nezempilo Ye-Radiological:
“Namuhla, i-FDA ixwayisa umphakathi kanye nabasebenzi bezempilo ukuthi bangasebenzisi izinto ezingenanaliti ezifana namapeni e-hyaluronic acid ukuze bajove i-hyaluronic acid noma ezinye izigcwalisi zomlomo nobuso, ezibizwa ngokuhlanganyela njengezigcwalisi zesikhumba noma izigcwalisi.Umsebenzi oyinhloko we-FDA ukuvikela iziguli , Bangase bangaqapheli izehlakalo ezimbi kakhulu ezihlobene nokusetshenziswa kwazo, njengokulimala unomphela esikhumbeni, ezindebeni, nasemehlweni.
Iziguli nabahlinzeki bezempilo kufanele bazi ukuthi i-FDA ayizange ivume noma yiziphi izigcwalisi zesikhumba ezisetshenziswa ekhaya noma ukuthengiswa kwe-counter-the-counter ukuze zisetshenziswe namadivayisi womjovo ongenanaliti.Lawa madivayisi namafayili angenanalithi angagunyaziwe athengiswa ngokuqondile kumakhasimende aku-inthanethi, kudlule ukubonisana nabahlinzeki bokunakekelwa kwezempilo abanelayisensi, okuyisinyathelo esibalulekile sokuphepha sokuthi iziguli zenze izinqumo ezinolwazi mayelana nempilo yazo.
I-FDA iqapha lawa madivayisi angagunyaziwe angenanaliti kanye nezinkundla eziku-inthanethi zamafayili e-dermal asetshenziswa kumishini yomjovo engenanaliti.Sithemba futhi ukuthi iziguli nabahlinzeki bahlala beqaphile mayelana nokuthi yimiphi imikhiqizo egunyazwe i-FDA kanye nezingozi zokusebenzisa imikhiqizo engagunyaziwe, eminye yayo engenakuhlehliswa.I-FDA izoqhubeka nokukhumbuza umphakathi futhi ithathe ezinye izinyathelo uma kunesidingo ukuvikela impilo yomphakathi.”
I-FDA iyisikhungo esingaphansi koMnyango Wezempilo Nezinsizakalo Zabantu wase-US evikela impilo yomphakathi ngokuqinisekisa ukuphepha, ukusebenza kahle, nokuphepha kwemithi yabantu neyezilwane, imigomo kanye neminye imikhiqizo yebhayoloji yabantu, kanye nezisetshenziswa zezokwelapha.I-ejensi futhi ibhekele ukuphepha nokuvikeleka kokuhlinzekwa kokudla kwezwe lethu, izimonyo, izithasiselo zokudla, kanye nemikhiqizo ekhipha imisebe ye-electronic, kanye nokulawula imikhiqizo kagwayi.


Isikhathi sokuthumela: Nov-02-2021