美國(guó)FDA醫(yī)療器械中英文術(shù)語(yǔ)
800 總則 GENERAL
801 標(biāo)識(shí) LABELING
803 醫(yī)療器械報(bào)告 MEDICAL DEVICE REPORTING
806 醫(yī)療器械；改正與移動(dòng)的報(bào)告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
807 對(duì)器械的制造者與首次進(jìn)口者的機(jī)構(gòu)登記與器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808 對(duì)州和地方醫(yī)療器械要求的聯(lián)邦優(yōu)先權(quán)的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS （奧咨達(dá)醫(yī)療器械咨詢）
809 人用體外診斷產(chǎn)品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 醫(yī)療器械召回權(quán) MEDICAL DEVICE RECALL AUTHORITY
812 試驗(yàn)用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS
813 [預(yù)留的] [Reserved]
814 醫(yī)療器械的上市前批準(zhǔn) PREMARKET APPROVAL OF MEDICAL DEVICES
820 質(zhì)量體系規(guī)章 QUALITY SYSTEM REGULATION
821 醫(yī)療器械跟蹤要求 MEDICAL DEVICE TRACKING REQUIREMENTS（只專注于醫(yī)療器械領(lǐng)域）
822 上市后監(jiān)視 POSTMARKET SURVEILLANCE
860 醫(yī)療器械分類(lèi)程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES
861 性能標(biāo)準(zhǔn)制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862 臨床化學(xué)與臨床毒理學(xué)器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864 血液學(xué)與病理學(xué)器械 HEMATOLOGY AND PATHOLOGY DEVICES
866 免疫學(xué)與微生物學(xué)器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES
868 麻醉學(xué)器械 ANESTHESIOLOGY DEVICES
870 心血管器械 CARDIOVASCULAR DEVICES
872 牙科器械 DENTAL DEVICES
874 耳、鼻和咽器械 EAR, NOSE, AND THROAT DEVICES
876 胃腸病學(xué)-泌尿?qū)W器械 GASTROENTEROLOGY-UROLOGY DEVICES
878 普通與整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES
880 普通醫(yī)院與個(gè)人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神經(jīng)學(xué)器械 NEUROLOGICAL DEVICES
884 產(chǎn)科與婦科學(xué)器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES
886 眼科器械 OPHTHALMIC DEVICES
888 矯形外科器械 ORTHOPEDIC DEVICES
890 內(nèi)科學(xué)器械 PHYSICAL MEDICINE DEVICES
892 放射學(xué)器械 RADIOLOGY DEVICES
895 禁止的器械 BANNED DEVICES
898 電極鉛線與患者電纜的性能標(biāo)準(zhǔn) PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
第I分章―乳房造影質(zhì)量標(biāo)準(zhǔn)法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）
900 乳房造影法 MAMMOGRAPHY
第J分章―放射學(xué)的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）
1000 總則 GENERAL
1002 記錄與報(bào)告 RECORDS AND REPORTS
1003 缺陷與未能守法的通報(bào) NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004 電子產(chǎn)品的回購(gòu)、修理或者置換 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
1005 電子產(chǎn)品的進(jìn)口 IMPORTATION OF ELECTRONIC PRODUCTS
1010 電子產(chǎn)品的性能標(biāo)準(zhǔn)：總則 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020 電離輻射發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030 微波與射電頻率發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040 發(fā)光產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050 聲波、次聲波和超聲波發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
第K分章―[預(yù)留的]（SUBCHAPTER K―[RESERVED]）
第L分章―根據(jù)由食品與藥品管理局行政執(zhí)行的某些其他法的規(guī)章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）
1210 根據(jù)《聯(lián)邦進(jìn)口乳法》的規(guī)章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230 根據(jù)《聯(lián)邦腐蝕性毒物法》的規(guī)章 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240 傳染病的控制 CONTROL OF COMMUNICABLE DISEASES
1250 州際運(yùn)輸衛(wèi)生 INTERSTATE CONVEYANCE SANITATION
1251-1269 [預(yù)留的] [Reserved]
1270 預(yù)期用于移植的人體組織 HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271 人體細(xì)胞、組織以及細(xì)胞的和基于組織的產(chǎn)品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
1272-1299 [預(yù)留的] [Reserved]
第Ⅱ章―司法部毒品強(qiáng)制執(zhí)行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定義 DEFINITIONS
1301 管制物質(zhì)的制造者、分銷(xiāo)者和調(diào)劑者的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 對(duì)管制物質(zhì)的標(biāo)識(shí)與包裝要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定額 QUOTAS
1304 登記者的記錄與報(bào)告 RECORDS AND REPORTS OF REGISTRANTS
1305 令的格式 ORDER FORMS
1306 處方 PRESCRIPTIONS
1307 雜項(xiàng) MISCELLANEOUS
1308 管制物質(zhì)的表 SCHEDULES OF CONTROLLED SUBSTANCES
1309 表I化學(xué)品的制造者、分銷(xiāo)者、進(jìn)口者和出口者的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310 列入表的化學(xué)品和某些機(jī)器的記錄與報(bào)告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
1311 [預(yù)留的] [Reserved]
1312 管制物質(zhì)的進(jìn)口與出口 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313 前體與必要化學(xué)品的進(jìn)口與出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
1314-1315 [預(yù)留的] [Reserved]
1316 行政職能、規(guī)范和程序 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
第Ⅲ章―毒品控制政策辦公室（CHAPTER Ⅲ―Office of National Drug Control Policy）
1400 [預(yù)留的] [Reserved]
1401 信息的公眾可及性 PUBLIC AVAILABILITY OF INFORMATION
1402 強(qiáng)制性解密審查 MANDATORY DECLASSIFICATION REVIEW
1403 對(duì)給予州和地方政府資金和合作協(xié)議的統(tǒng)一行政要求 UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS
1404 政府范圍的排除與暫停（非獲得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
1405 對(duì)無(wú)毒品工作場(chǎng)所的政府范圍的要求（財(cái)政援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)
【責(zé)任編輯：博朗筆譯】