「의료기기 허가ㆍ신고ㆍ심사 등에 관한 규정」제28조제3항에 따라
생물학적 안전에 관한 자료의 면제 대상을 다음과 같이 공고합니다.
의료기기 생물학적 안전성시험 자료제출 면제 대상 공고
8. 미국 FDA Code of Federal Regulations Title 21, Part 73에 등록된 색소를 사용한 의료기기
(콘택트렌즈, 봉합사에 한함)
(1) 미국 FDA Code of Federal Regulations Title 21, Part 73에는 인증 면제 색상 첨가제 목록이 나와있음
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A - GENERAL
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Part A, B, C, D로 나뉘고 의료기기는 Part D를 참고하면 되고,
Part A 음식(Foods)
Part B 의약품(Drugs)
Part C 화장품(Cosmetics)
Part D 의료기기(Medical devices)
컨택트렌즈나 봉합사의 경우에만 해당된다. 만약 좀 애매하면 심사기관 문의하자
Subpart D - Medical Devices
§ 73.3100 - 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.
§ 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
§ 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers.
§ 73.3107 - Carbazole violet.
§ 73.3110 - Chlorophyllin-copper complex, oil soluble.
§ 73.3110a - Chromium-cobalt-aluminum oxide.
§ 73.3111 - Chromium oxide greens.
§ 73.3112 - C.I. Vat Orange 1.
§ 73.3115 - 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
§ 73.3117 - 16,23-Dihydrodinaphtho[2,3-a:2',3'-i] naphth [2',3':6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.
§ 73.3118 - N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
§ 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
§ 73.3120 - 16,17-Dimethoxydinaphtho [1,2,3-cd:3',2',1'-lm] perylene-5,10-dione.
§ 73.3121 - Poly(hydroxyethyl methacrylate)-dye copolymers.
§ 73.3122 - 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.
§ 73.3123 - 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.
§ 73.3124 - Phthalocyanine green.
§ 73.3125 - Iron oxides.
§ 73.3126 - Titanium dioxide.
§ 73.3127 - Vinyl alcohol/methyl methacrylate-dye reaction products.
§ 73.3128 - Mica-based pearlescent pigments.
§ 73.3129 - Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.
하위 파트 D - 의료 기기
§ 73.3100 - 1,4-비스[(2-하이드록시에틸)아미노]-9,10-안트라센디온 비스(2-메틸-2-프로펜산)에스테르 공중합체.
§ 73.3105 - 1,4-비스[(2-메틸페닐)아미노]-9,10-안트라센디온.
§ 73.3106 - 1,4-비스[4-(2-메타크릴옥시에틸)페닐아미노]안트라퀴논 공중합체.
§ 73.3107 - 카르바졸 바이올렛.
§ 73.3110 - 클로로필린-구리 복합체, 오일 용해성.
§ 73.3110a - 크롬-코발트-알루미늄 산화물.
§ 73.3111 - 크롬 산화물 그린.
§ 73.3112 - C.I. Vat Orange 1.
§ 73.3115 - 2-[[2,5-디에톡시-4-[(4-메틸페닐)티올]페닐]아조]-1,3,5-벤젠트리올.
§ 73.3117 - 16,23-디히드로디나프토[2,3-a:2',3'-i] 나프탈[2',3':6,7] 인돌로[2,3-c] 카바졸-5,10,15,17,22,24-헥손.
§ 73.3118 - N,N'-(9,10-디히드로-9,10-디옥소-1,5-안트라센디일) 비스벤자미드.
§ 73.3119 - 7,16-디클로로-6,15-디하이드로-5,9,14,18-안트라진테트론.
§ 73.3120 - 16,17-디메톡시디나프토[1,2,3-cd:3',2',1'-lm]페릴렌-5,10-디온.
§ 73.3121 - 폴리(하이드록시에틸 메타크릴레이트)염료 공중합체.
§ 73.3122 - 4-[(2,4-디메틸페닐)아조]-2,4-디하이드로-5-메틸-2-페닐-3H-피라졸-3-온.
§ 73.3123 - 6-에톡시-2-(6-에톡시-3-옥소벤조[b]티엔-2(3H)-일리덴) 벤조[b]티오펜-3(2H)-온.
§ 73.3124 - 프탈로시아닌 그린.
§ 73.3125 - 산화철.
§ 73.3126 - 이산화티타늄.
§ 73.3127 - 비닐 알코올/메틸 메타크릴레이트-염료 반응 생성물.
§ 73.3128 - 마이카 기반 진주광택 안료.
§ 73.3129 - 디소듐 1-아미노-4-[[4-[(2-브로모-1-옥소알릴)아미노]-2-설포나토페닐]아미노]-9,10-디하이드로-9,10-디옥소안트라센-2-설포네이트.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=73
CFR - Code of Federal Regulations Title 21
TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A - GENERAL Subpart A - Foods § 73.1 - Diluents in color additive mixtures for food use exempt from certification. § 73.30 - Ann
www.accessdata.fda.gov
