G\u0131da ve \u0130la\u00e7 \u0130daresi (FDA), Amerika Birle\u015fik Devletleri Sa\u011fl\u0131k ve \u0130nsan Hizmetleri Departman\u0131nda bir kurumdur. Halk sa\u011fl\u0131\u011f\u0131n\u0131n korunmas\u0131 ile ilgili bir\u00e7ok sorumlulu\u011fu vard\u0131r. Ajans\u0131n ila\u00e7lar ve t\u0131bbi cihazlarla ilgili sorumluluklar\u0131, bunlar\u0131n g\u00fcvenli, etkili ve uygun \u015fekilde etiketlenmesini sa\u011flamakt\u0131r. FDA ayr\u0131ca halk\u0131n sa\u011fl\u0131klar\u0131n\u0131 iyile\u015ftirmek i\u00e7in kullan\u0131labilecek t\u0131bbi cihazlar ve ila\u00e7lar hakk\u0131nda do\u011fru bilgi almas\u0131na yard\u0131mc\u0131 olur. Di\u011fer sorumluluklar aras\u0131nda t\u00fct\u00fcn y\u00f6netmeli\u011fi, halk\u0131 elektronik \u00fcr\u00fcn radyasyonundan koruma ve g\u0131dalar, veteriner ila\u00e7lar\u0131, a\u015f\u0131lar, kozmetikler ve diyet takviyeleri ile ilgili halk sa\u011fl\u0131\u011f\u0131n\u0131 koruma yer al\u0131r.<\/p>\n
\u0130la\u00e7 De\u011ferlendirme ve Ara\u015ft\u0131rma Merkezi (CDER), FDA'n\u0131n hem re\u00e7eteli hem de re\u00e7etesiz sat\u0131lan ila\u00e7lar\u0131 d\u00fczenleyen b\u00f6l\u00fcm\u00fcd\u00fcr. Antidepresanlar, a\u011fr\u0131 kesiciler ve antibiyotikler gibi re\u00e7eteli ila\u00e7lar\u0131 d\u00fczenlemeye ek olarak CDER, g\u00fcne\u015f kremi, flor\u00fcrl\u00fc di\u015f macunu ve hatta terlemeyi \u00f6nleyici gibi re\u00e7etesiz sat\u0131lan \u00fcr\u00fcnleri de d\u00fczenlemektedir. T\u00fcm re\u00e7eteli ila\u00e7lar\u0131n Amerika Birle\u015fik Devletleri'nde sat\u0131labilmesi i\u00e7in FDA onay\u0131na sahip olmas\u0131 gerekir. S\u00fcre\u00e7 tipik olarak laboratuvar testlerini, insan testlerini ve ard\u0131ndan test sonu\u00e7lar\u0131, \u00fcretim bilgileri ve ama\u00e7lanan amac\u0131, riskleri, faydalar\u0131 vb. gibi ila\u00e7 i\u00e7in \u00f6nerilen etiketi i\u00e7eren bir ba\u015fvurunun FDA'ya sunulmas\u0131n\u0131 i\u00e7erir. FDA bu ba\u015fvuruyu g\u00f6zden ge\u00e7irecek ve yararlar\u0131n\u0131n bilinen risklerden daha fazla oldu\u011funu ve uygun \u015fekilde \u00fcretilebilece\u011fini tespit ederse ilac\u0131 onaylayabilir.<\/p>\n
\u0130la\u00e7lar gibi, t\u0131bbi cihazlar da FDA taraf\u0131ndan d\u00fczenlenir. Cihazlar ve Radyolojik Sa\u011fl\u0131k Merkezi (CDRH), t\u0131bbi cihazlar\u0131 ithal eden, tasarlayan, \u00fcreten, yeniden paketleyen ve yeniden etiketleyen \u015firketleri d\u00fczenleme g\u00f6revine sahiptir. ABD'de bir t\u0131bbi cihaz satmakla ilgilenen bir \u015firketin FDA'ya ya 510(k) ya da pazar \u00f6ncesi onay (PMA) ba\u015fvurusu yapmas\u0131 gerekir. Cihaz, halihaz\u0131rda onaylanm\u0131\u015f ve ayn\u0131 kullan\u0131m i\u00e7in pazarlanan bir cihaza "esas olarak e\u015fde\u011fer" ise, bir 510(k) dosyalan\u0131r. Di\u011fer durumlarda bir PMA ba\u015fvurusu yap\u0131l\u0131r. Bir PMA uygulamas\u0131yla \u015firket, cihaz\u0131n makul \u00f6l\u00e7\u00fcde g\u00fcvenli ve etkili oldu\u011funu kan\u0131tlamal\u0131d\u0131r.<\/p>\n
At times, FDA-approved drugs or medical devices cause injury to patients. The information provided to the FDA may have been incomplete or inaccurate. The drug company or manufacturer of the medical device may have been negligent in testing the drug or product. Certain side effects may only arise after long-term use of the product. A manufacturer may market the drug or device for the wrong purpose or may make misleading statements as to the purpose of the product. Whatever the reason for the product\u2019s initial approval and subsequent harm, patients may be left injured and families may lose loved ones.<\/p>\n
Patients and healthcare providers can and should report adverse reactions to the FDA through the MedWatch<\/a> system. The agency uses these reports to compile information on prescription drugs and medical devices. It uses these reports to conduct its own studies and may review other studies to ascertain whether a product should remain on the market. Depending on the findings of a study, the FDA may require the warning label for the product to be updated, issuing a safety alert or warning. It may also request that the manufacturer remove the product from the market altogether, through a recall.<\/p>\n