510(k)vsOTC专论vsNDA/ANDA：合规路径怎么选
企业常把510(k)、OTC专论、NDA/ANDA混为一谈。本文厘清：510(k)是医疗器械路径，OTC专论与NDA/ANDA才是药品路径；并给出按产品属性选路径的决策框架，避免走错赛道浪费数月。
化妆品出口美国需要FDA批准吗？注册与批准的区别
许多企业混淆「FDA注册」与「FDA批准」。本文明确：普通化妆品出口美国无需上市前批准，但须完成MoCRA强制注册列名；而宣称功效的OTC药品则需走专论或NDA路径。厘清两者边界，避免无证上市或被误导付费买「批准函」。
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human Use
21 CFR Part 331 -- Antacid Products for Over-the-Counter (OTC) Human UsePART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:39 FR 19874, June 4, 1974, unless otherwise noted.Subpa
21 CFR Part 333 Subpart B - First Aid Antibiotic Drug Products
21 CFR Part 333 Subpart B - First Aid Antibiotic Drug ProductsSubpart B—First Aid Antibiotic Drug Products§ 333.101 Scope.(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human Use
21 CFR Part 347 - Skin Protectant Drug Products for Over-the-Counter Human UsePART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:58 FR 54462, Oct. 21, 1993, unless otherwi
21 CFR Part 350 - Antiperspirant Drug Products for Over-the-Counter Human Use
21 CFR Part 350 - Antiperspirant Drug Products for Over-the-Counter Human UsePART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:68 FR 34291, June 9, 2003, unless otherwise
21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
21 CFR Part 352 - Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:64 FR 2768
21 CFR Part 355 - Anticaries Drug Products for Over-the-Counter Human Use
21 CFR Part 355 - Anticaries Drug Products for Over-the-Counter Human UsePART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:60 FR 52507, Oct. 6, 1995, unless otherwise noted.Ed
21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human Use
21 CFR Part 358 - Miscellaneous External Drug Products for Over-the-Counter Human UsePART 358—MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEAuthority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.Source:55 FR 33255, Aug. 14, 1990,
21 CFR Part 358 Subpart D—Ingrown Toenail Relief Drug Products
21 CFR Part 358 Subpart D—Ingrown Toenail Relief Drug ProductsSubpart D—Ingrown Toenail Relief Drug ProductsSource:68 FR 24348, May 7, 2003, unless otherwise noted.§ 358.301 Scope.(a) An over-the-counter ingrown toenail relief drug product in a form
