ABSTRACT
WAIVER 12.30 JUDICIAL REVIEW AFTER WAIVER OF HEARING ON A REGULATION Initiation Of Proceedings; Formal Evidentiary Public Hearing
WAIVER 20.43 WAIVER OR REDUCTION OF FEES Procedures And Fees; Public Information
WAIVER 56.105 WAIVER OF IRB REQUIREMENT General Provisions; Institutional Review Boards
WAIVER 201.58 REQUESTS FOR WAIVER OF REQUIREMENT FOR ADEQUATE AND WELLCONTROLLED STUDIES TO SUBSTANTIATE CERTAIN LABELING STATEMENTS Labeling Requirements For Prescription Drugs And/or Insulin; Labeling
WAIVER 320.22 CRITERIA FOR WAIVER OF EVIDENCE OF IN VIVO BIOAVAILABILITY OR BIOEQUIVALENCE Procedures For Determining The Bioavailability Or Bioequivalence Of Drug Products; Bioavailability And Bioequivalence Requirements
WAIVER 500.90 WAIVER OF REQUIREMENTS Regulation of Carcinogenic Compounds Used In Food-Producing Animals; General
WAIVER 1301.43 REQUEST FOR HEARING OR APPEARANCE; WAIVER Hearings; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
WAIVER 1309.29 WAIVER OF REGISTRATION REQUIREMENT FOR CERTAIN ACTIVITIES Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
WAIVER 1303.33 WAIVER OF MODIFICATION OF RULES Hearings; Quotas
WAIVER 1303.34 REQUEST FOR HEARING OR APPEARANCE; WAIVER Hearings; Quotas
WAIVER 1308.45 REQUEST FOR HEARING OR APPEARANCE; WAIVER Hearings; Schedules Of Controlled Substances
WAIVER 1309.53 REQUEST FOR HEARING OR APPEARANCE; WAIVER Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
WAIVER 1312.43 WAIVER OR MODIFICATION OF RULES Hearings; Importation And Exportation Of Controlled Substances
WAIVER 1312.44 REQUEST FOR HEARING OR APPEARANCE; WAIVER Hearings; Importation And Exportation Of Controlled Substances
WAIVER 1313.15 WAIVER OF 15-DAY ADVANCE NOTICE FOR REGULAR IMPORTERS Importation Of Listed Chemicals; Importation And Exportation Of Precursors And Essential Chemicals
WAIVER 1313.24 WAIVER OF 15-DAY ADVANCE NOTICE FOR CHEMICAL EXPORTERS Exportation Of Listed Chemicals; Importation And Exportation Of Precursors And Essential Chemicals
WAIVER 1313.53 WAIVER OR MODIFICATION OF RULES Importation And Exportation Of Precursors And Essential Chemicals
WAIVER 1316.44 WAIVER OR MODIFICATION OF RULES Administrative Hearings; Administrative Functions, Practices, And Procedures
WAIVER 1316.49 WAIVER OF HEARING Administrative Hearings; Administrative Functions, Practices, And Procedures
WAIVER 1401.13 WAIVER OR REDUCTION OF FEES Public Availability Of Information
WAIVERS 5.30 AUTHORITY TO SELECT TEMPORARY VOTING MEMBERS OF ADVISORY COMMITTEES AND AUTHORITY TO SIGN CONFLICT OF INTEREST WAIVERS General Redelegations Of Authority; Delegations Of Authority And Organization
WAIVERS 5.108 AUTHORITY RELATING TO WAIVERS OR REDUCTIONS OF PRESCRIPTION DRUG USER FEES Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
WAIVERS 312.10 WAIVERS Investigational New Drug Application
WAIVERS 314.90 WAIVERS Applications; Applications For FDA Approval To Market A New Drug
WAIVERS 600.90 WAIVERS Reporting Of Adverse Experiences; Biological Products: General
WAIVERS 812.10 WAIVERS General Provisions; Investigational Device Exemptions
WALKER 890.3825 MECHANICAL WALKER
Physical Medicine Prosthetic Devices; Physical Medicine Devices
WARDS 50.56 WARDS Additional Safeguards For Children In Clinical Investigations; Protection Of Human Subjects
WAREHOUSING 110.93 WAREHOUSING AND DISTRIBUTION Production And Process Controls; Current GMP In Manufacturing, Packing, Or Holding Human Food
WAREHOUSING 211.142 WAREHOUSING PROCEDURES Holding And Distribution; Current Good Manufacturing Practice For Finished Pharmaceuticals
WARMER 872.6100 ANESTHETIC WARMER Miscellaneous Devices; Dental Devices
WARMER 880.5130 INFANT RADIANT WARMER General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
WARMING DEVICE 864.9205 BLOOD AND PLASMA WARMING DEVICE Products Used In Establishments That Manufacture Blood And Blood Products; Hematology And Pathology Devices
WARNING 101.17 FOOD LABELING WARNING, NOTICE, AND SAFE HANDLING STATEMENTS General Provisions; Food Labeling
WARNING 201.22 PRESCRIPTION DRUGS CONTAINING SULFITES; REQUIRED WARNING STATEMENTS General Labeling Provisions; Labeling
WARNING 201.309 ACETOPHENETIDIN (PHENACETIN)-CONTAINING PREPARATIONS; NECESSARY WARNING STATEMENT Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 201.315 OVER-THE-COUNTER DRUGS FOR MINOR SORE THROATS; SUGGESTED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 201.316 DRUGS WITH THYROID HORMONE ACTIVITY FOR HUMAN USE; REQUIRED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 201.317 DIGITALIS AND RELATED CARDIOTONIC DRUGS FOR HUMAN USE IN ORAL DOSAGE FORMS; REQUIRED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 201.320 WARNING STATEMENTS FOR DRUG PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 201.322 OVER-THE COUNTER DRUG PRODUCTS CONTAINING INTERNAL ANALGESIC/ANTIPYRETIC ACTIVE INGREDIENTS; REQUIRED ALCOHOL WARNING Specific Labeling Requirements For Specific Drug Products; Labeling
WARNING 290.5 DRUGS; STATEMENT OF REQUIRED WARNING General Provisions; Controlled Drugs
WARNING 369.8 WARNING STATEMENTS IN RELATION TO CONDITIONS FOR USE Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNING 369.10 CONSPICUOUSNESS OF WARNING STATEMENTS Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNING 369.20 DRUGS; RECOMMENDED WARNING AND CAUTION STATEMENTS Warning And Caution Statements For Drugs; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNING 369.21 DRUGS; WARNING AND CAUTION STATEMENTS REQUIRED BY REGULATIONS Warning And Caution Statements For Drugs; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNING 369.22 DRUGS; WARNING AND CAUTION STATEMENTS SPECIFICALLY REQUIRED BY LAW Warning And Caution Statements For Drugs; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNING 501.17 ANIMAL FOOD LABELING WARNING STATEMENTS General Provisions; Animal Food Labeling
WARNING 740.1 ESTABLISHMENT OF WARNING STATEMENTS General; Cosmetic Product Warning Statements
WARNING 740.2 CONSPICUOUSNESS OF WARNING STATEMENTS General; Cosmetic Product Warning Statements
WARNING 801.63 MEDICAL DEVICES; WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS Labeling Requirements For Over-the-counter Devices; Labeling
PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS Specific Requirements For Specific Devices; Labeling
WARNING, LIMB OVERLOAD 890.5575 POWERED EXTERNAL LIMB OVERLOAD WARNING DEVICE Physical Medicine Therapeutic Devices; Physical Medicine Devices
WARNING, PREGNANCY/ 201.63 PREGNANCY/BREAST-FEEDING WARNING BREAST-FEEDING Labeling Requirements For Over-the-counter Drugs; Labeling
WARNING, PREGNANCY-330.2 PREGNANCY-NURSING WARNING NURSING General Provisions; Over-the-counter Human Drugs Generally Recognized As Safe
And Effective & Not Misbranded WARNING, SPANISH 290.6 SPANISH-LANGUAGE VERSION OF REQUIRED WARNING
General Provisions; Controlled Drugs WARNINGS 201.305 ISOPROTERENOL INHALATION PREPARATIONS (PRESSURIZED AEROSOLS,
NEBULIZERS, POWDERS) FOR HUMAN USE; WARNINGS Specific Labeling Requirements For Specific Drug Products; Labeling
WARNINGS 201.307 SODIUM PHOSPHATES; PACKAGE SIZE LIMITATION, WARNINGS AND DIRECTIONS FOR OVER-THE-COUNTER SALE Specific Labeling Requirements For Specific Drug Products; Labeling
WARNINGS 201.308 IPECAC SYRUP; WARNINGS AND DIRECTIONS FOR USE FOR OVER-THECOUNTER SALE Specific Labeling Requirements For Specific Drug Products; Labeling
WARNINGS 201.319 WATER-SOLUBLE GUMS, HYDROPHILIC GUMS AND HYDROPHILIC MUCILLOIDS AS ACTIVE INGREDIENTS; REQUIRED WARNINGS AND DIRECTIONS Specific Labeling Requirements For Specific Drug Products; Labeling
WARNINGS 369.3 WARNINGS REQUIRED ON DRUGS EXEMPTED FROM PRESCRIPTIONDISPENSING REQUIREMENTS OF SECTION 503(B)(1)(C) Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNINGS 369.4 WARNINGS SUGGESTED FOR DRUGS BY FORMAL OR INFORMAL STATEMENTS OF POLICY Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNINGS 369.7 WARNINGS REQUIRED BY OFFICIAL COMPENDIA Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNINGS 369.9 GENERAL WARNINGS RE ACCIDENTAL INGESTION BY CHILDREN Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale
WARNINGS 510.410 CORTICOSTEROIDS FOR ORAL, INJECTABLE, AND OPHTHALMIC USE IN ANIMALS; WARNINGS AND LABELING REQUIREMENTS Requirements For Specific New Animal Drugs; New Animal Drugs
WARRANT 1316.07 REQUIREMENT FOR ADMINISTRATIVE INSPECTION WARRANT; EXCEPTIONS Administrative Inspections; Administrative Functions, Practices, And Procedures
WARRANT 1316.09 APPLICATION FOR ADMINISTRATIVE INSPECTION WARRANT Administrative Inspections; Administrative Functions, Practices, And Procedures
WARRANT 1316.12 REFUSAL TO ALLOW INSPECTION WITH AN ADMINISTRATIVE WARRANT Administrative Inspections; Administrative Functions, Practices, And Procedures
WARRANTS 1316.11 EXECUTION OF WARRANTS Administrative Inspections; Administrative Functions, Practices, And Procedures
WART REMOVER 358.110 WART REMOVER ACTIVE INGREDIENTS Wart Remover Drug Products; Miscellaneous External Drug Products For Over-thecounter Human Use
WART REMOVER 358.150 LABELING OF WART REMOVER DRUG PRODUCTS Wart Remover Drug Products; Miscellaneous External Drug Products For Over-thecounter Human Use
WASH WATER 1250.87 WASH WATER Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WASHED CURD CHEESE 133.136 WASHED CURD AND SOAKED CURD CHEESE Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
WASHED CURD CHEESE 133.137 WASHED CURD CHEESE FOR MANUFACTURING Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
WASHER 884.1185 ENDOMETRIAL WASHER Obstetrical And Gynecological Diagnostic Devices; Obstetrical And Gynecological Devices
WASHERS 880.6800 WASHERS FOR BODY WASTE RECEPTACLES General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
AND VEGETABLES Specific Usage Additives; Secondary Direct Food Additives Permitted In Food For Human Consumption
WASHING FACILITIES 211.52 WASHING AND TOILET FACILITIES Buildings And Facilities; Current Good Manufacturing Practice For Finished Pharmaceuticals
WASHINGTON 808.97 WASHINGTON Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
WASTE 880.6730 BODY WASTE RECEPTACLE General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WASTE 880.6800 WASHERS FOR BODY WASTE RECEPTACLES General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WASTES 1250.51 RAILROAD CONVEYANCES; DISCHARGE OF WASTES Equipment And Operation Of Land And Air Conveyances; Interstate Conveyance Sanitation
WASTES 1250.52 DISCHARGE OF WASTES ON HIGHWAY CONVEYANCES Equipment And Operation Of Land And Air Conveyances; Interstate Conveyance Sanitation
WASTES 1250.53 DISCHARGE OF WASTES ON AIR CONVEYANCES Equipment And Operation Of Land And Air Conveyances; Interstate Conveyance Sanitation
WASTES 1250.70 DISPOSAL OF HUMAN WASTES Servicing Areas For Land And Air Conveyances; Interstate Conveyance Sanitation
WASTES 1250.93 DISCHARGE OF WASTES Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER 1250.83 STORAGE OF WATER PRIOR TO TREATMENT Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER 1250.84 WATER IN GALLEYS AND MEDICAL CARE SPACES Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER 1250.86 WATER FOR MAKING ICE Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER 1250.87 WASH WATER Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER BOATS 1240.95 SANITATION OF WATER BOATS Source And Use Of Potable Water; Control Of Communicable Diseases
WATER, BOILER 173.310 BOILER WATER ADDITIVES Specific Usage Additives; Secondary Direct Food Additives Permitted In Food For Human Consumption
WATER BOTTLE 880.6085 HOT/COLD WATER BOTTLE General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WATER, BOTTLED 165.110 BOTTLED WATER Requirements For Specific Standardized Beverages; Beverages
WATER CALORIC STIMULATOR 874.1800 AIR OR WATER CALORIC STIMULATOR Diagnostic Devices; Ear, Nose, And Throat Devices
WATER CAPACITY 130.12 GENERAL METHODS FOR WATER CAPACITY AND FILL OF CONTAINERS General Provisions; Food Standards: General
WATER CIRCULATING 890.5720 WATER CIRCULATING HOT OR COLD PACK Physical Medicine Therapeutic Devices; Physical Medicine Devices
WATER, DRINKING 520.100 AMPROLIUM DRINKING WATER Oral Dosage Form New Animal Drugs
WATER, DRINKING 520.1242 LEVAMISOLE HYDROCHLORIDE DRENCH AND DRINKING WATER Oral Dosage Form New Animal Drugs
WATER, DRINKING 520.2200b SULFACHLORPYRIDAZINE MEDICATED MILK AND DRINKING WATER Oral Dosage Form New Animal Drugs
WATER, DRINKING 520.2240a SULFAETHOXYPYRIDAZINE DRINKING WATER Oral Dosage Form New Animal Drugs
WATER, DRINKING 520.2261a SULFAMETHAZINE SODIUM DRINKING WATER SOLUTION Oral Dosage Form New Animal Drugs
WATER, DRINKING 520.2325 SULFAQUINOXALINE DRINKING WATER Oral Dosage Form New Animal Drugs
WATER, DRINKING/CULINARY 1240.80 GENERAL REQUIREMENTS FOR WATER FOR DRINKING AND CULINARY PURPOSES Source And Use Of Potable Water; Control Of Communicable Diseases
WATER ICES 135.160 WATER ICES Requirements For Specific Standardized Frozen Desserts; Frozen Desserts
WATER-INSOLUBLE 177.1400 HYDROXYETHYL CELLULOSE FILM, WATER-INSOLUBLE
Surgical Devices; Gastroenterology-urology Devices
WATER, LUNG 868.2450 LUNG WATER MONITOR Monitoring Devices; Anesthesiology Devices
WATER MATTRESS 880.5560 TEMPERATURE REGULATED WATER MATTRESS General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
WATER PURIFICATION 876.5665 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Therapeutic Devices; Gastroenterology-urology Devices
WATER PURIFICATION 884.6170 ASSISTED REPRODUCTION WATER AND WATER PURIFICATION SYSTEMS Assisted Reproduction Devices; Obstetrical And Gynecological Devices
WATER PURIFIER 880.6710 MEDICAL ULTRAVIOLET WATER PURIFIER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WATER RESISTANT 352.76 DETERMINATION IF PRODUCT IS WATER RESISTANT OR VERY WATER RESISTANT Sunscreen Drug Products For Over-the-counter Human Use
WATER-SOLUBLE GUMS 201.319 WATER-SOLUBLE GUMS, HYDROPHILIC GUMS AND HYDROPHILIC MUCILLOIDS AS ACTIVE INGREDIENTS; REQUIRED WARNINGS AND DIRECTIONS Specific Labeling Requirements For Specific Drug Products; Labeling
WATER STERILIZER 872.6710 BOILING WATER STERILIZER Miscellaneous Devices; Dental Devices
WATER SYSTEM 1240.86 PROTECTION OF PIER WATER SYSTEM Source And Use Of Potable Water; Control Of Communicable Diseases
WATER SYSTEMS 1250.42 WATER SYSTEMS; CONSTANT TEMPERATURE BOTTLES Equipment And Operation Of Land And Air Conveyances; Interstate Conveyance Sanitation
WATER SYSTEMS 1250.82 POTABLE WATER SYSTEMS Sanitation Facilities And Conditions On Vessels; Interstate Conveyance Sanitation
WATER TRAP 868.5995 TEE DRAIN (WATER TRAP) Therapeutic Devices; Anesthesiology Devices
WATER VAPOR 868.1975 WATER VAPOR ANALYZER Diagnostic Devices; Anesthesiology Devices
WATERING EQUIPMENT 1250.67 WATERING EQUIPMENT Servicing Areas For Land And Air Conveyances; Interstate Conveyance Sanitation
WATERING POINTS 1240.83 APPROVAL OF WATERING POINTS Source And Use Of Potable Water; Control Of Communicable Diseases
WAVE, SHOCK 876.5990 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER Therapeutic Devices; Gastroenterology-urology Devices
WAX 178.3850 REINFORCED WAX Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
WAX BEANS 155.120 CANNED GREEN BEANS AND CANNED WAX BEANS Requirements For Specific Standardized Canned Vegetables; Canned Vegetables
WAX, BRAN 172.890 RICE BRAN WAX Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WAX, CANDELILLA 184.1976 CANDELILLA WAX Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WAX, CARNAUBA 184.1978 CARNAUBA WAX Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WAX, CARNAUBA 582.1978 CARNAUBA WAX General Purpose Food Additives; Substances Generally Recognized As Safe
WAX, DENTAL 872.6890 INTRAORAL DENTAL WAX Miscellaneous Devices; Dental Devices
WAX, JAPAN 186.1555 JAPAN WAX Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe
WAX, MONTAN 178.3770 POLYHYDRIC ALCOHOL ESTERS OF OXIDATIVELY REFINED (GERSTHOFEN PROCESS) MONTAN WAX ACIDS Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
WAX, PETROLEUM 172.886 PETROLEUM WAX Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WAX, PETROLEUM 172.888 SYNTHETIC PETROLEUM WAX Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
WEIGHING 864.9195 BLOOD MIXING DEVICES AND BLOOD WEIGHING DEVICES Products Used In Establishments That Manufacture Blood And Blood Products; Hematology And Pathology Devices
WEIGHT, BODY 105.66 LABEL STATEMENTS RELATING TO USEFULNESS IN REDUCING OR MAINTAINING BODY WEIGHT Label Statements; Foods For Special Dietary Use
WEIGHT, MOLECULAR 172.820 POLYETHYLENE GLYCOL (MEAN MOLECULAR WEIGHT 200-9,500) Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WEIGHT, MOLECULAR 177.1440 4,4’-ISOPROPYLIDENEDIPHENOL-EPICHLOROHYDRIN RESINS MINIMUM MOLECULAR WEIGHT 10,000 Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
WEIGHT, MOLECULAR 178.3750 POLYETHYLENE GLYCOL (MEAN MOLECULAR WEIGHT 200-9,500) Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
WEIL-FELIX 866.3410 PROTEUS SPP. (WEIL-FELIX) SEROLOGICAL REAGENTS Serological Reagents; Immunology And Microbiology Devices
WELFARE 50.54 CLINICAL INVESTIGATIONS NOT OTHERWISE APPROVABLE THAT PRESENT AN OPPORTUNITY TO UNDERSTAND, PREVENT, OR ALLEVIATE A SERIOUS PROBLEM AFFECTING THE HEALTH OR WELFARE OF CHILDREN Additional Safeguards For Children In Clinical Investigations; Protection Of Human Subjects
WELL-CONTROLLED STUDIES 201.58 REQUESTS FOR WAIVER OF REQUIREMENT FOR ADEQUATE AND WELLCONTROLLED STUDIES TO SUBSTANTIATE CERTAIN LABELING STATEMENTS Labeling Requirements For Prescription Drugs And/or Insulin; Labeling
WELL-CONTROLLED STUDIES 314.126 ADEQUATE AND WELL-CONTROLLED STUDIES FDA Action On Applications; Applications For FDA Approval To Market A New Drug
WELL-CONTROLLED STUDIES 514.117 ADEQUATE AND WELL-CONTROLLED STUDIES Administrative Actions On Applications; New Animal Drug Applications
WEST VIRGINIA 808.98 WEST VIRGINIA Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
WET PACK SHRIMP 161.173 CANNED WET PACK SHRIMP IN TRANSPARENT OR NONTRANSPARENT CONTAINERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
WHEAT 136.180 WHOLE WHEAT BREAD, ROLLS, AND BUNS Requirements For Specific Standardized Bakery Products; Bakery Products
WHEAT 137.190 CRACKED WHEAT Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHEAT 137.195 CRUSHED WHEAT Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHEAT 137.200 WHOLE WHEAT FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHEAT 137.205 BROMATED WHOLE WHEAT FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHEAT 139.138 WHOLE WHEAT MACARONI PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
WHEAT 139.140 WHEAT AND SOY MACARONI PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
WHEAT 139.180 WHEAT AND SOY NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
WHEAT GLUTEN 184.1322 WHEAT GLUTEN Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WHEELCHAIR 890.3850 MECHANICAL WHEELCHAIR Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3860 POWERED WHEELCHAIR Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3880 SPECIAL GRADE WHEELCHAIR
Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3910 WHEELCHAIR ACCESSORY Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3920 WHEELCHAIR COMPONENT Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3930 WHEELCHAIR ELEVATOR Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELCHAIR 890.3940 WHEELCHAIR PLATFORM SCALE Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELED 890.3800 MOTORIZED THREE-WHEELED VEHICLE Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEELED STRETCHER 880.6910 WHEELED STRETCHER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WHEELED STRETCHER 890.3690 POWERED WHEELED STRETCHER Physical Medicine Prosthetic Devices; Physical Medicine Devices
WHEY 184.1979 WHEY Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WHEY 184.1979a REDUCED LACTOSE WHEY Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WHEY 184.1979b REDUCED MINERALS WHEY Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
WHEY 573.450 FERMENTED AMMONIATED CONDENSED WHEY Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
WHIPPED CREAM 131.25 WHIPPED CREAM PRODUCTS CONTAINING FLAVORING OR SWEETENING General Provisions; Milk And Cream
WHIPPING CREAM 131.157 LIGHT WHIPPING CREAM Requirements For Specific Standardized Milk And Cream; Milk And Cream
WHITE CELL 864.8185 CALIBRATOR FOR RED CELL AND WHITE CELL COUNTING Hematology Reagents; Hematology And Pathology Devices
WHITE CORN 137.211 WHITE CORN FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHITE CORN 137.250 WHITE CORN MEAL Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHITE CORN 137.255 BOLTED WHITE CORN MEAL Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHITE CORN 137.265 DEGERMINATED WHITE CORN MEAL Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHITE CORN 137.270 SELF-RISING WHITE CORN MEAL Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHITE MINERAL OIL 172.878 WHITE MINERAL OIL Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WHITES, EGG 160.140 EGG WHITES Requirements For Specific Standardized Eggs And Egg Products; Eggs And Egg Products
WHITES, EGG 160.145 DRIED EGG WHITES Requirements For Specific Standardized Eggs And Egg Products; Eggs And Egg Products
WHITES, EGG 160.150 FROZEN EGG WHITES Requirements For Specific Standardized Eggs And Egg Products; Eggs And Egg Products
WHITING 102.46 PACIFIC WHITING Requirements For Specific Nonstandardized Foods; Common Or Usual Name For Nonstandardized Foods
WHOLE 12.28 DENIAL OF HEARING IN WHOLE OR IN PART Initiation Of Proceedings; Formal Evidentiary Public Hearing
WHOLE BLOOD 640.1 WHOLE BLOOD Whole Blood; Additional Standards For Human Blood And Blood Products
WHOLE BLOOD 640.6 MODIFICATIONS OF WHOLE BLOOD Whole Blood; Additional Standards For Human Blood And Blood Products
Hematology Kits And Packages; Hematology And Pathology Devices
WHOLE BODY 892.1130 NUCLEAR WHOLE BODY COUNTER Diagnostic Devices; Radiology Devices
WHOLE BODY 892.1330 NUCLEAR WHOLE BODY SCANNER Diagnostic Devices; Radiology Devices
WHOLE MILK 131.147 DRY WHOLE MILK Requirements For Specific Standardized Milk And Cream; Milk And Cream
WHOLE DURUM FLOUR 137.225 WHOLE DURUM FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHOLE FISH PROTEIN 172.385 WHOLE FISH PROTEIN CONCENTRATE Special Dietary And Nutritional Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WHOLE PLASMA 866.5700 WHOLE HUMAN PLASMA OR SERUM IMMUNOLOGICAL TEST SYSTEM Immunological Test Systems; Immunology And Microbiology Devices
WHOLE WHEAT 136.180 WHOLE WHEAT BREAD, ROLLS, AND BUNS Requirements For Specific Standardized Bakery Products; Bakery Products
WHOLE WHEAT 137.200 WHOLE WHEAT FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHOLE WHEAT 137.205 BROMATED WHOLE WHEAT FLOUR Requirements For Specific Standardized Cereal Flours And Related Products; Cereal Flours And Related Products
WHOLE WHEAT 139.138 WHOLE WHEAT MACARONI PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
WHOLESALE DISTRIBUTION 203.50 REQUIREMENTS FOR WHOLESALE DISTRIBUTION OF PRESCRIPTION DRUGS Prescription Drug Marketing
WHOLESALE DISTRIBUTOR 205.4 WHOLESALE DRUG DISTRIBUTOR LICENSING REQUIREMENT Guidelines For State Licensing Of Wholesale Prescription Drug Distributors
WINE BOTTLES 189.301 TIN-COATED LEAD FOIL CAPSULES FOR WINE BOTTLES Substances Prohibited From Use In Human Foods
WINTERGREEN OIL 201.303 LABELING OF DRUG PREPARATIONS CONTAINING SIGNIFICANT PROPORTIONS OF WINTERGREEN OIL Specific Labeling Requirements For Specific Drug Products; Labeling
WIRE 870.1330 CATHETER GUIDE WIRE Cardiovascular Diagnostic Devices; Cardiovascular Devices
WIRE 872.4600 INTRAORAL LIGATURE AND WIRE LOCK Surgical Devices; Dental Devices
WIRE 872.4880 INTRAOSSEOUS FIXATION SCREW OR WIRE Surgical Devices; Dental Devices
WITHDRAW APPROVAL 5.102 AUTHORITY TO APPROVE AND WITHDRAW APPROVAL OF A CHARGE FOR INVESTIGATIONAL NEW DRUGS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
WITHDRAW APPROVAL 5.105 ISSUANCE OF NOTICES RELATING TO PROPOSALS TO REFUSE APPROVAL OR TO WITHDRAW APPROVAL OF NEW DRUG APPLICATIONS AND THEIR SUPPLEMENTS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
WITHDRAW RECOGNITION 5.400 ISSUANCE OF FEDERAL REGISTER DOCUMENTS TO RECOGNIZE OR TO WITHDRAW RECOGNITION OF A STANDARD TO MEET PREMARKET SUBMISSION REQUIREMENTS Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
WITHDRAWAL 870.1800 WITHDRAWAL-INFUSION PUMP Cardiovascular Diagnostic Devices; Cardiovascular Devices
WITHDRAWAL OF APPLICATION 314.65 WITHDRAWAL BY THE APPLICANT OF AN UNAPPROVED APPLICATION Applications; Applications For FDA Approval To Market A New Drug
WITHDRAWAL OF APPLICATIONS 514.7 WITHDRAWAL OF APPLICATIONS WITHOUT PREJUDICE General Provisions; New Animal Drug Applications
WITHDRAWAL OF APPLICATIONS 1301.16 AMENDMENTS TO AND WITHDRAWAL OF APPLICATIONS Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
WITHDRAWAL OF APPROVAL 5.407 APPROVAL, DISAPPROVAL, OR WITHDRAWAL OF APPROVAL OF PRODUCT DEVELOPMENT PROTOCOLS AND APPLICATIONS FOR PREMARKET APPROVAL FOR MEDICAL DEVICES Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
AND ENTERING INTO AGREEMENTS FOR INVESTIGATIONAL DEVICE EXEMPTIONS Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
WITHDRAWAL OF APPROVAL 314.150 WITHDRAWAL OF APPROVAL OF AN APPLICATION OR ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
WITHDRAWAL OF APPROVAL 314.151 WITHDRAWAL OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION UNDER SECTION 505(J)(5) OF THE ACT Applications For FDA Approval To Market A New Drug
WITHDRAWAL OF APPROVAL 314.152 NOTICE OF WITHDRAWAL OF APPROVAL OF AN APPLICATION OR ABBREVIATED APPLICATION FOR A NEW DRUG FDA Action On Applications; Applications For FDA Approval To Market A New Drug
WITHDRAWAL OF APPROVAL 514.115 WITHDRAWAL OF APPROVAL OF APPLICATIONS Administrative Actions On Applications; New Animal Drug Applications
WITHDRAWAL OF APPROVAL 514.116 NOTICE OF WITHDRAWAL OF APPROVAL OF APPLICATION Administrative Actions On Applications; New Animal Drug Applications
WITHDRAWAL OF APPROVAL 814.46 WITHDRAWAL OF APPROVAL OF A PMA FDA Action On A PMA; Premarket Approval Of Medical Devices
WITHDRAWAL OF APPROVAL 814.118 DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF AN HDE Humanitarian Use Devices; Premarket Approval Of Medical Devices
WITHDRAWAL OF APPROVAL 900.6 WITHDRAWAL OF APPROVAL Accreditation; Mammography
WITHDRAWAL OF APPROVAL 900.24 WITHDRAWAL OF APPROVAL States As Certifiers; Mammography
WITHDRAWAL, CONFORMITY 26.68 WITHDRAWAL OF LISTED CONFORMITY ASSESSMENT BODIES ASSESSMENT Framework Provisions; Mutual Recognition Of Pharmaceutical GMP Reports,
Medical Device Quality System Audit Reports WITHDRAWAL, IND 312.38 WITHDRAWAL OF AN IND
Investigational New Drug Application WITHDRAWAL, LISTED DRUG 314.161 DETERMINATION OF REASONS FOR VOLUNTARY WITHDRAWAL OF A
LISTED DRUG Applications For FDA Approval To Market A New Drug
WITHDRAWAL OF PETITION 171.7 WITHDRAWAL OF PETITION WITHOUT PREJUDICE General Provisions; Food Additive Petitions
WITHDRAWAL OF PETITION 571.7 WITHDRAWAL OF PETITION WITHOUT PREJUDICE General Provisions; Food Additive Petitions
WITHDRAWAL OF PETITIONS 71.6 EXTENSION OF TIME FOR STUDYING PETITIONS; SUBSTANTIVE AMENDMENTS; WITHDRAWAL OF PETITIONS WITHOUT PREJUDICE General Provisions; Color Additive Petitions
WITHDRAWAL OF RECORDS 20.29 PROHIBITION ON WITHDRAWAL OF RECORDS FROM FDA FILES General Policy; Public Information
WITHDRAWAL PROCEDURES 314.530 WITHDRAWAL PROCEDURES Accelerated Approval Of New Drugs; Applications For FDA Approval To Market A New Drug
WITHDRAWAL PROCEDURES 601.43 WITHDRAWAL PROCEDURES Accelerated Approval Of Biological Products; Licensing
WITHDRAWALS OF APPLICATIONS 1309.36 AMENDMENTS TO AND WITHDRAWALS OF APPLICATIONS Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
WITHDRAWING APPROVAL 514.120 REVOCATION OF ORDER REFUSING TO APPROVE AN APPLICATION OR SUSPENDING OR WITHDRAWING APPROVAL OF AN APPLICATION Administrative Actions On Applications; New Animal Drug Applications
WITHDRAWN 216.24 DRUG PRODUCTS WITHDRAWN OR REMOVED FROM THE MARKET FOR REASONS OF SAFETY OR EFFECTIVENESS Pharmacy Compounding
WITHDRAWN 314.160 APPROVAL OF AN APPLICATION OR ABBREVIATED APPLICATION FOR WHICH APPROVAL WAS PREVIOUSLY REFUSED, SUSPENDED, OR WITHDRAWN FDA Action On Applications; Applications For FDA Approval To Market A New Drug
WITNESS 17.25 EXCHANGE OF WITNESS LISTS, WITNESS STATEMENTS, AND EXHIBITS Civil Money Penalties Hearings
WITNESSES 17.37 WITNESSES Civil Money Penalties Hearings
WITNESSES 1316.57 SUBMISSION OF DOCUMENTARY EVIDENCE AND AFFIDAVITS AND IDENTIFICATION OF WITNESSES SUBSEQUENT TO PREHEARING CONFERENCE Administrative Hearings; Administrative Functions, Practices, And Procedures
WOOD 178.3800 PRESERVATIVES FOR WOOD Certain Adjuvants And Production Aids; Indirect Food Additives: Adjuvants,
Other Specific Usage Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
WOOD’S FLUORESCENT LAMP 866.2600 WOOD’S FLUORESCENT LAMP Microbiology Devices; Immunology And Microbiology Devices
WORK AREAS 225.35 USE OF WORK AREAS, EQUIPMENT, AND STORAGE AREAS FOR OTHER MANUFACTURING AND STORAGE PURPOSES Construction And Maintenance Of Facilities And Equipment; Current Good Manufacturing Practice For Medicated Feeds
WORK AREAS 225.135 WORK AND STORAGE AREAS Facilities And Equipment; Current Good Manufacturing Practice For Medicated Feeds
WOUND DRESSING 878.4018 HYDROPHILIC WOUND DRESSING Surgical Devices; General And Plastic Surgery Devices
WOUND DRESSING 878.4020 OCCLUSIVE WOUND DRESSING Surgical Devices; General And Plastic Surgery Devices
WOUND DRESSING 878.4022 HYDROGEL WOUND DRESSING AND BURN DRESSING Surgical Devices; General And Plastic Surgery Devices
WOUND HEALING 310.534 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OTC FOR HUMAN USE AS ORAL WOUND HEALING AGENTS Requirements For Specific New Drugs Or Devices; New Drugs
WRAP 880.6850 STERILIZATION WRAP General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
WRIST JOINT 888.3750 WRIST JOINT CARPAL LUNATE POLYMER PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3760 WRIST JOINT CARPAL SCAPHOID POLYMER PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3770 WRIST JOINT CARPAL TRAPEZIUM POLYMER PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3780 WRIST JOINT POLYMER CONSTRAINED PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3790 WRIST JOINT METAL CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3800 WRIST JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRIST JOINT 888.3810 WRIST JOINT ULNAR (HEMI-WRIST) POLYMER PROSTHESIS Prosthetic Devices; Orthopedic Devices
WRITING 14.174 ADVICE AND RECOMMENDATIONS IN WRITING Advisory Committees For Human Prescription Drugs; Public Hearing Before A Public Advisory Committee
WRITTEN APPROVAL 1312.31 SCHEDULE I: APPLICATION FOR PRIOR WRITTEN APPROVAL Transshipment And In-transit Shipment Of Controlled Substances; Importation And Exportation Of Controlled Substances
WRITTEN NOTICES 5.109 ISSUANCE OF WRITTEN NOTICES CONCERNING PATENT INFORMATION, CURRENT GOOD MANUFACTURING PRACTICES AND FALSE OR MISLEADING LABELING OF NEW DRUGS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
WRITTEN NOTICES 5.504 ISSUANCE OF WRITTEN NOTICES CONCERNING PATENT INFORMATION, CURRENT GOOD MANUFACTURING PRACTICES AND FALSE OR MISLEADING LABELING OF NEW ANIMAL DRUGS AND FEEDS BEARING OR CONTAINING NEW ANIMAL DRUGS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
WRITTEN PROCEDURES 211.100 WRITTEN PROCEDURES; DEVIATIONS Production And Process Controls; Current Good Manufacturing Practice For Finished Pharmaceuticals
WRITTEN PROCEDURES 803.17 WRITTEN MDR PROCEDURES General Provisions; Medical Device Reporting
WRITTEN PROCEDURES 1270.9 WRITTEN PROCEDURES Human Tissue Intended For Transplantation
WRITTEN RECOMMENDATIONS 316.10 CONTENT AND FORMAT OF A REQUEST FOR WRITTEN RECOMMENDATIONS Orphan Drugs
WRITTEN RECOMMENDATIONS 316.12 PROVIDING WRITTEN RECOMMENDATIONS Orphan Drugs
WRITTEN RECOMMENDATIONS 316.14 REFUSAL TO PROVIDE WRITTEN RECOMMENDATIONS Orphan Drugs
WRITTEN REQUEST 810.12 WRITTEN REQUEST FOR REVIEW OF CEASE DISTRIBUTION AND
Meeting Procedures; Public Hearing Before A Public Advisory Committee
WRITTEN SUBMISSIONS 15.25 WRITTEN SUBMISSIONS Procedures For Public Hearing Before The Commissioner; Public Hearing Before The Commissioner
WRITTEN TESTIMONY 12.87 PURPOSE; ORAL AND WRITTEN TESTIMONY; BURDEN OF PROOF Hearing Procedures; Formal Evidentiary Public Hearing