CFR - Code of Federal Regulations Title 21

FDA Home
Medical Devices
Databases

This information is current as of April 1, 2016.

This online reference for CFR Title 21 is updated once a year. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Learn More...

Search Database

Help

Title21 Part.Section (e.g., 862.1385)	Full Text Search
CFR Title 21 - Food and Drugs: Parts 1 to 1499
		Clear Form

CFR - Code of Federal Regulations Title 21

Links on this page:

Links on this page:

(1) General enforcement regulations
(2) General administrative rulings and decisions
(3) Product jurisdiction
(4) Regulation of combination products
(5) Organization
(7) Enforcement policy
(10) Administrative practices and procedures
(11) Electronic records; electronic signatures
(12) Formal evidentiary public hearing
(13) Public hearing before a public board of inquiry
(14) Public hearing before a public advisory committee
(15) Public hearing before the commissioner
(16) Regulatory hearing before the food and drug administration
(17) Civil money penalties hearings
(19) Standards of conduct and conflicts of interest
(20) Public information
(21) Protection of privacy
(25) Environmental impact considerations
(26) Mutual recognition of pharmaceutical good manufacturing prac ...
(50) Protection of human subjects
(54) Financial disclosure by clinical investigators
(56) Institutional review boards
(58) Good laboratory practice for nonclinical laboratory studies
(60) Patent term restoration
(70) Color additives
(71) Color additive petitions
(73) Listing of color additives exempt from certification
(74) Listing of color additives subject to certification
(80) Color additive certification
(81) General specifications and general restrictions for provisio ...
(82) Listing of certified provisionally listed colors and specifi ...
(83-98) [reserved]
(99) Dissemination of information on unapproved/new uses for mark ...
(100) General
(101) Food labeling
(102) Common or usual name for nonstandardized foods
(104) Nutritional quality guidelines for foods
(105) Foods for special dietary use
(106) Infant formula requirements pertaining to current good manuf ...
(107) Infant formula
(108) Emergency permit control
(109) Unavoidable contaminants in food for human consumption and f ...
(110) Current good manufacturing practice in manufacturing, packin ...
(111) Current good manufacturing practice in manufacturing, packag ...
(112) Standards for the growing, harvesting, packing, and holding ...
(113) Thermally processed low-acid foods packaged in hermetically ...
(114) Acidified foods
(115) Shell eggs
(117) Current good manufacturing practice, hazard analysis, and ri ...
(118) Production, storage, and transportation of shell eggs
(119) Dietary supplements that present a significant or unreasonab ...
(120) Hazard analysis and critical control point (haccp) systems
(121) Mitigation strategies to protect food against intentional ad ...
(123) Fish and fishery products
(129) Processing and bottling of bottled drinking water
(130) Food standards: general
(131) Milk and cream
(133) Cheeses and related cheese products
(135) Frozen desserts
(136) Bakery products
(137) Cereal flours and related products
(139) Macaroni and noodle products
(145) Canned fruits
(146) Canned fruit juices
(150) Fruit butters, jellies, preserves, and related products
(152) Fruit pies
(155) Canned vegetables
(156) Vegetable juices
(158) Frozen vegetables
(160) Eggs and egg products
(161) Fish and shellfish
(163) Cacao products
(164) Tree nut and peanut products
(165) Beverages
(166) Margarine
(168) Sweeteners and table sirups
(169) Food dressings and flavorings
(170) Food additives
(171) Food additive petitions
(172) Food additives permitted for direct addition to food for hum ...
(173) Secondary direct food additives permitted in food for human ...
(174) Indirect food additives: general
(175) Indirect food additives: adhesives and components of coating ...
(176) Indirect food additives: paper and paperboard components
(177) Indirect food additives: polymers
(178) Indirect food additives: adjuvants, production aids, and san ...
(179) Irradiation in the production, processing and handling of fo ...
(180) Food additives permitted in food or in contact with food on ...
(181) Prior-sanctioned food ingredients
(182) Substances generally recognized as safe
(184) Direct food substances affirmed as generally recognized as s ...
(186) Indirect food substances affirmed as generally recognized as ...
(189) Substances prohibited from use in human food
(190) Dietary supplements
(191-199) [reserved]
(200) General
(201) Labeling
(202) Prescription drug advertising
(203) Prescription drug marketing
(205) Guidelines for state licensing of wholesale prescription dru ...
(206) Imprinting of solid oral dosage form drug products for human ...
(207) Registration of producers of drugs and listing of drugs in c ...
(208) Medication guides for prescription drug products
(209) Requirement for authorized dispensers and pharmacies to dist ...
(210) Current good manufacturing practice in manufacturing, proces ...
(211) Current good manufacturing practice for finished pharmaceuti ...
(212) Current good manufacturing practice for positron emission to ...
(216) Pharmacy compounding
(225) Current good manufacturing practice for medicated feeds
(226) Current good manufacturing practice for type a medicated art ...
(250) Special requirements for specific human drugs
(290) Controlled drugs
(299) Drugs; official names and established names
(300) General
(310) New drugs
(312) Investigational new drug application
(314) Applications for fda approval to market a new drug
(315) Diagnostic radiopharmaceuticals
(316) Orphan drugs
(317) Qualifying pathogens
(320) Bioavailability and bioequivalence requirements
(328) Over-the-counter drug products intended for oral ingestion t ...
(329) Nonprescription human drug products subject to section 760 o ...
(330) Over-the-counter (otc) human drugs which are generally recog ...
(331) Antacid products for over-the-counter (otc) human use
(332) Antiflatulent products for over-the-counter human use
(333) Topical antimicrobial drug products for over-the-counter hum ...
(335) Antidiarrheal drug products for over-the-counter human use
(336) Antiemetic drug products for over-the-counter human use
(338) Nighttime sleep-aid drug products for over-the-counter human ...
(340) Stimulant drug products for over-the-counter human use
(341) Cold, cough, allergy, bronchodilator, and antiasthmatic drug ...
(343) Internal analgesic, antipyretic, and antirheumatic drug prod ...
(344) Topical otic drug products for over-the-counter human use
(346) Anorectal drug products for over-the-counter human use
(347) Skin protectant drug products for over-the-counter human use
(348) External analgesic drug products for over-the-counter human ...
(349) Ophthalmic drug products for over-the-counter human use
(350) Antiperspirant drug products for over-the-counter human use
(352) Sunscreen drug products for over-the-counter human use [stay ...
(355) Anticaries drug products for over-the-counter human use
(357) Miscellaneous internal drug products for over-the-counter hu ...
(358) Miscellaneous external drug products for over-the-counter hu ...
(361) Prescription drugs for human use generally recognized as saf ...
(369) Interpretative statements re warnings on drugs and devices f ...
(370-499) [reserved]
(500) General
(501) Animal food labeling
(502) Common or usual names for nonstandardized animal foods
(507) Current good manufacturing practice, hazard analysis, and ri ...
(509) Unavoidable contaminants in animal food and food-packaging m ...
(510) New animal drugs
(511) New animal drugs for investigational use
(514) New animal drug applications
(515) Medicated feed mill license
(516) New animal drugs for minor use and minor species
(520) Oral dosage form new animal drugs
(522) Implantation or injectable dosage form new animal drugs
(524) Ophthalmic and topical dosage form new animal drugs
(526) Intramammary dosage form new animal drugs
(528) New animal drugs in genetically engineered animals
(529) Certain other dosage form new animal drugs
(530) Extralabel drug use in animals
(556) Tolerances for residues of new animal drugs in food
(558) New animal drugs for use in animal feeds
(564) [reserved]
(570) Food additives
(571) Food additive petitions
(573) Food additives permitted in feed and drinking water of anima ...
(579) Irradiation in the production, processing, and handling of a ...
(582) Substances generally recognized as safe
(584) Food substances affirmed as generally recognized as safe in ...
(589) Substances prohibited from use in animal food or feed
(590-599) [reserved]
(600) Biological products: general
(601) Licensing
(606) Current good manufacturing practice for blood and blood comp ...
(607) Establishment registration and product listing for manufactu ...
(610) General biological products standards
(630) Requirements for blood and blood components intended for tra ...
(640) Additional standards for human blood and blood products
(660) Additional standards for diagnostic substances for laborator ...
(680) Additional standards for miscellaneous products
(700) General
(701) Cosmetic labeling
(710) Voluntary registration of cosmetic product establishments
(720) Voluntary filing of cosmetic product ingredient composition ...
(740) Cosmetic product warning statements
(741-799) [reserved]
(800) General
(801) Labeling
(803) Medical device reporting
(806) Medical devices; reports of corrections and removals
(807) Establishment registration and device listing for manufactur ...
(808) Exemptions from federal preemption of state and local medica ...
(809) In vitro diagnostic products for human use
(810) Medical device recall authority
(812) Investigational device exemptions
(813) [reserved]
(814) Premarket approval of medical devices
(820) Quality system regulation
(821) Medical device tracking requirements
(822) Postmarket surveillance
(830) Unique device identification
(860) Medical device classification procedures
(861) Procedures for performance standards development
(862) Clinical chemistry and clinical toxicology devices
(864) Hematology and pathology devices
(866) Immunology and microbiology devices
(868) Anesthesiology devices
(870) Cardiovascular devices
(872) Dental devices
(874) Ear, nose, and throat devices
(876) Gastroenterology-urology devices
(878) General and plastic surgery devices
(880) General hospital and personal use devices
(882) Neurological devices
(884) Obstetrical and gynecological devices
(886) Ophthalmic devices
(888) Orthopedic devices
(890) Physical medicine devices
(892) Radiology devices
(895) Banned devices
(898) Performance standard for electrode lead wires and patient ca ...
(900) Mammography
(1000) General
(1002) Records and reports
(1003) Notification of defects or failure to comply
(1004) Repurchase, repairs, or replacement of electronic products
(1005) Importation of electronic products
(1010) Performance standards for electronic products: general
(1020) Performance standards for ionizing radiation emitting produc ...
(1030) Performance standards for microwave and radio frequency emit ...
(1040) Performance standards for light-emitting products
(1050) Performance standards for sonic, infrasonic, and ultrasonic ...
(1100) Tobacco products subject to fda authority
(1105) [reserved]
(1107) Establishment registration, product listing, and substantial ...
(1140) Cigarettes, smokeless tobacco, and covered tobacco products
(1141) Cigarette package and advertising warnings
(1143) Minimum required warning statements
(1150) User fees
(1210) Regulations under the federal import milk act
(1230) Regulations under the federal caustic poison act
(1240) Control of communicable diseases
(1250) Interstate conveyance sanitation
(1251-1269) [reserved]
(1270) Human tissue intended for transplantation
(1271) Human cells, tissues, and cellular and tissue-based products
(1272-1299) [reserved]
(1300) Definitions
(1301) Registration of manufacturers, distributors, and dispensers ...
(1302) Labeling and packaging requirements for controlled substance ...
(1303) Quotas
(1304) Records and reports of registrants
(1305) Orders for schedule i and ii controlled substances
(1306) Prescriptions
(1307) Miscellaneous
(1308) Schedules of controlled substances
(1309) Registration of manufacturers, distributors, importers and e ...
(1310) Records and reports of listed chemicals and certain machines
(1311) Requirements for electronic orders and prescriptions
(1312) Importation and exportation of controlled substances
(1313) Importation and exportation of list i and list ii chemicals
(1314) Retail sale of scheduled listed chemical products
(1315) Importation and production quotas for ephedrine, pseudoephed ...
(1316) Administrative functions, practices, and procedures
(1317) Disposal
(1321) Dea mailing addresses
(1322-1399) [reserved]
(1400) [reserved]
(1401) Public availability of information
(1402) Mandatory declassification review
(1403-1499) [reserved]