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ULTRASONIC CLEANER 880.6150 ULTRASONIC CLEANER FOR MEDICAL INSTRUMENTS General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices

ULTRASONIC DIATHERMY 890.5300 ULTRASONIC DIATHERMY Physical Medicine Therapeutic Devices; Physical Medicine Devices

ULTRASONIC IMAGER 884.2225 OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices

ULTRASONIC IMAGING 892.1550 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM Diagnostic Devices; Radiology Devices

ULTRASONIC IMAGING 892.1560 ULTRASONIC PULSED ECHO IMAGING SYSTEM Diagnostic Devices; Radiology Devices

ULTRASONIC MONITOR 868.2025 ULTRASONIC AIR EMBOLISM MONITOR Monitoring Devices; Anesthesiology Devices

ULTRASONIC MONITOR 884.2660 FETAL ULTRASONIC MONITOR AND ACCESSORIES Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices

ULTRASONIC MONITOR 892.1540 NONFETAL ULTRASONIC MONITOR Diagnostic Devices; Radiology Devices

ULTRASONIC SCALER 872.4850 ULTRASONIC SCALER Surgical Devices; Dental Devices

ULTRASONIC SCANNER 882.1925 ULTRASONIC SCANNER CALIBRATION TEST BLOCK Neurological Diagnostic Devices; Neurological Devices

ULTRASONIC THERAPY 1050.10 ULTRASONIC THERAPY PRODUCTS Performance Standards For Sonic, Infrasonic, And Ultrasonic Radiation-emitting Products

ULTRASONIC TRANSDUCER 870.2880 ULTRASONIC TRANSDUCER Cardiovascular Monitoring Devices; Cardiovascular Devices

ULTRASONIC TRANSDUCER 884.2960 OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices

ULTRASONIC TRANSDUCER 892.1570 DIAGNOSTIC ULTRASONIC TRANSDUCER Diagnostic Devices; Radiology Devices

ULTRAVIOLET ACTIVATOR 872.6070 ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION Miscellaneous Devices; Dental Devices

ULTRAVIOLET DETECTOR 872.6350 ULTRAVIOLET DETECTOR Miscellaneous Devices; Dental Devices

ULTRAVIOLET LAMP 878.4630 ULTRAVIOLET LAMP FOR DERMATOLOGIC DISORDERS Surgical Devices; General And Plastic Surgery Devices

ULTRAVIOLET LAMP 878.4635 ULTRAVIOLET LAMP FOR TANNING Surgical Devices; General And Plastic Surgery Devices

ULTRAVIOLET LAMPS 1040.20 SUNLAMP PRODUCTS AND ULTRAVIOLET LAMPS INTENDED FOR USE IN SUNLAMP PRODUCTS Performance Standards For Light-emitting Products

ULTRAVIOLET PURIFIER 880.6500 MEDICAL ULTRAVIOLET AIR PURIFIER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices

ULTRAVIOLET PURIFIER 880.6710 MEDICAL ULTRAVIOLET WATER PURIFIER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices

ULTRAVIOLET RADIATION 179.39 ULTRAVIOLET RADIATION FOR THE PROCESSING AND TREATMENT OF FOOD Radiation And Radiation Sources; Irradiation In The Production, Processing And Handling Of Food

UMBILICAL 880.5950 UMBILICAL OCCLUSION DEVICE General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices

UNACCEPTABLE 640.76 PRODUCTS STORED OR SHIPPED AT UNACCEPTABLE TEMPERATURES Source Plasma; Additional Standards For Human Blood And Blood Products

Applications; Applications For FDA Approval To Market A New Drug

UNAPPROVED APPLICATION 314.65 WITHDRAWAL BY THE APPLICANT OF AN UNAPPROVED APPLICATION Applications; Applications For FDA Approval To Market A New Drug

UNAPPROVED APPLICATION 314.96 AMENDMENTS TO AN UNAPPROVED ABBREVIATED APPLICATION Abbreviated Applications; Applications For FDA Approval To Market A New Drug

UNAPPROVED DRUGS 5.801 EXPORT OF UNAPPROVED DRUGS Imports And Exports; Redelegations Of Authority; Delegations Of Authority And Organization

UNAVAILABILITY 12.78 UNAVAILABILITY OF PRESIDING OFFICER Presiding Officer; Formal Evidentiary Public Hearing

UNAVOIDABILITY 109.7 UNAVOIDABILITY General Provisions; Unavoidable Contaminants In Food For Human Consumption & Food-packaging Material

UNAVOIDABILITY 509.7 UNAVOIDABILITY General Provisions; Unavoidable Contaminants In Animal Food And Foodpackaging Material

UNCERTAIN 20.45 SITUATIONS IN WHICH CONFIDENTIALITY IS UNCERTAIN Procedures And Fees; Public Information

UNCOMPENSATED 868.2320 UNCOMPENSATED THORPE TUBE FLOWMETER Monitoring Devices; Anesthesiology Devices

UNDECYLENATE 522.204 BOLDENONE UNDECYLENATE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs

UNIFORM ACCESS 20.21 UNIFORM ACCESS TO RECORDS General Policy; Public Information

UNIT 868.5655 PORTABLE LIQUID OXYGEN UNIT Therapeutic Devices; Anesthesiology Devices

UNIT 870.4300 CARDIOPULMONARY BYPASS GAS CONTROL UNIT Cardiovascular Surgical Devices; Cardiovascular Devices

UNIT 876.4300 ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES Surgical Devices; Gastroenterology-urology Devices

UNIT 880.5700 NEONATAL PHOTOTHERAPY UNIT General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices

UNIT 890.5940 CHILLING UNIT Physical Medicine Therapeutic Devices; Physical Medicine Devices

UNIT 890.5950 POWERED HEATING UNIT Physical Medicine Therapeutic Devices; Physical Medicine Devices

UNIT, QUALITY 58.35 QUALITY ASSURANCE UNIT Organization And Personnel; Good Laboratory Practice For Nonclinical Laboratory Studies

UNIT, QUALITY 211.22 RESPONSIBILITIES OF QUALITY CONTROL UNIT Organization And Personnel; Current Good Manufacturing Practice For Finished Pharmaceuticals

UNITS, SAMPLE 203.38 SAMPLE LOT OR CONTROL NUMBERS; LABELING OF SAMPLE UNITS Prescription Drug Marketing

UNITED STATES 17.54 DEPOSIT IN THE TREASURY OF THE UNITED STATES Civil Money Penalties Hearings

UNITED STATES 101.44 IDENTIFICATION OF THE 20 MOST FREQUENTLY CONSUMED RAW FRUIT, VEGETABLES, AND FISH IN THE UNITED STATES Food Labeling

UNITED STATES 807.40 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR FOREIGN ESTABLISHMENTS IMPORTING OR OFFERING FOR IMPORT DEVICES INTO THE UNITED STATES Registration Procedures For Foreign Device Establishments; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices

UNITED STATES 814.15 RESEARCH CONDUCTED OUTSIDE THE UNITED STATES General; Premarket Approval Of Medical Devices

UNITED STATES 1010.5 EXEMPTIONS FOR PRODUCTS INTENDED FOR UNITED STATES GOVERNMENT USE Performance Standards For Electronic Products: General

UNLICENSED ESTABLISHMENTS 606.171 REPORTING OF PRODUCT DEVIATIONS BY MANUFACTURERS, UNLICENSED BLOOD ESTABLISHMENTS, AND TRANSFUSION SERVICES Records And Reports; Current Good Manufacturing Practices For Blood And Blood Components

UNREASONABLE RISK 5.409 DETERMINATIONS THAT MEDICAL DEVICES PRESENT UNREASONABLE RISK OF SUBSTANTIAL HARM Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization

UNTESTED COMPONENTS 211.82 RECEIPT AND STORAGE OF UNTESTED COMPONENTS, DRUG PRODUCT CONTAINERS, AND CLOSURES

General Provisions; New Animal Drug Applications

UNUSED SUPPLY 312.59 DISPOSITION OF UNUSED SUPPLY OF INVESTIGATIONAL DRUG Investigational New Drug Application

UPDATING 207.30 UPDATING DRUG LISTING INFORMATION Procedures For Domestic Drug Establishments; Registration Of Drug Producers And Listing Of Drugs In Commercial Distribution

UPDATING 607.30 UPDATING BLOOD PRODUCT LISTING INFORMATION Procedures For Domestic Blood Product Establishments; Establishment Registratn+product Listing, Manufacturers Human Blood/b.products

UPDATING 807.30 UPDATING DEVICE LISTING INFORMATION Procedures For Device Establishments; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices

UPTAKE 862.1715 TRIIODOTHYRONINE UPTAKE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

UPTAKE 868.1730 OXYGEN UPTAKE COMPUTER Diagnostic Devices; Anesthesiology Devices

UPTAKE 886.1670 OPHTHALMIC ISOTOPE UPTAKE PROBE Diagnostic Devices; Ophthalmic Devices

UPTAKE 892.1320 NUCLEAR UPTAKE PROBE Diagnostic Devices; Radiology Devices

UREA 176.320 SODIUM NITRATE-UREA COMPLEX Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives: Paper And Paperboard Components

UREA 184.1923 UREA Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe

UREA-FORMALDEHYDE 177.1900 UREA-FORMALDEHYDE RESINS IN MOLDED ARTICLES Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers

UREA NITROGEN 862.1770 UREA NITROGEN TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

UREASE 184.1924 UREASE ENZYME PREPARATION FROM LACTOBACILLUS FERMENTUM Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe

URETERAL 876.4020 FIBEROPTIC LIGHT URETERAL CATHETER Surgical Devices; Gastroenterology-urology Devices

URETERAL 876.4620 URETERAL STENT Surgical Devices; Gastroenterology-urology Devices

URETERAL 876.4680 URETERAL STONE DISLODGER Surgical Devices; Gastroenterology-urology Devices

URETERAL 876.5470 URETERAL DILATOR Therapeutic Devices; Gastroenterology-urology Devices

URETHRAL 876.4590 INTERLOCKING URETHRAL SOUND Surgical Devices; Gastroenterology-urology Devices

URETHRAL 876.5520 URETHRAL DILATOR Therapeutic Devices; Gastroenterology-urology Devices

URETHROTOME 876.4770 URETHROTOME Surgical Devices; Gastroenterology-urology Devices

URIC ACID 862.1775 URIC ACID TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Toxicology Devices

URIDYL TRANSFERASE 862.1315 GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINALYSIS 862.2900 AUTOMATED URINALYSIS SYSTEM Clinical Laboratory Instruments; Clinical Chemistry And Clinical Toxicology Devices

URINARY BILIRUBIN 862.1115 URINARY BILIRUBIN AND ITS CONJUGATES (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINARY CALCULI 862.1780 URINARY CALCULI (STONES) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINARY CONTINENCE 876.5270 IMPLANTED ELECTRICAL URINARY CONTINENCE DEVICE Therapeutic Devices; Gastroenterology-urology Devices

URINARY CONTINENCE 876.5280 IMPLANTED MECHANICAL/HYDRAULIC URINARY CONTINENCE DEVICE Therapeutic Devices; Gastroenterology-urology Devices

URINARY HOMOCYSTINE 862.1377 URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology

Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINARY PHENYLKETONES 862.1560 URINARY PHENYLKETONES TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINARY UROBILINOGEN 862.1785 URINARY UROBILINOGEN (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URINE 876.1800 URINE FLOW OR VOLUME MEASURING SYSTEM Diagnostic Devices; Gastroenterology-urology Devices

URINE 876.5250 URINE COLLECTOR AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices

UROBILINOGEN 862.1785 URINARY UROBILINOGEN (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

URODYNAMICS 876.1620 URODYNAMICS MEASUREMENT SYSTEM Diagnostic Devices; Gastroenterology-urology Devices

UROLOGICAL 876.4890 UROLOGICAL TABLE AND ACCESSORIES Surgical Devices; Gastroenterology-urology Devices

UROLOGICAL 876.5090 SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices

UROLOGICAL 876.5130 UROLOGICAL CATHETER AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices

UROLOGICAL 876.5160 UROLOGICAL CLAMP FOR MALES Therapeutic Devices; Gastroenterology-urology Devices

UROLOGY 876.1075 GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT Diagnostic Devices; Gastroenterology-urology Devices

UROLOGY 876.4370 GASTROENTEROLOGY-UROLOGY EVACUATOR Surgical Devices; Gastroenterology-urology Devices

UROLOGY 876.4530 GASTROENTEROLOGY-UROLOGY FIBEROPTIC RETRACTOR Surgical Devices; Gastroenterology-urology Devices

UROLOGY 876.4730 MANUAL GASTROENTEROLOGY-UROLOGY SURGICAL INSTRUMENT AND ACCESSORIES Surgical Devices; Gastroenterology-urology Devices

UROPORPHYRIN 862.1790 UROPORPHYRIN TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

U.S. GOVERNMENT 1002.51 EXEMPTIONS FOR MANUFACTURERS OF PRODUCTS INTENDED FOR THE U.S. GOVERNMENT Exemptions From Records And Reports Requirements; Records and Reports

U.S. STANDARD 640.55 U.S. STANDARD PREPARATION Cryoprecipitate; Additional Standards For Human Blood And Blood Products

USAGE CRITERIA 211.122 MATERIALS EXAMINATION AND USAGE CRITERIA Packaging And Labeling Control; Current Good Manufacturing Practice For Finished Pharmaceuticals

USE, CONDITIONS 369.8 WARNING STATEMENTS IN RELATION TO CONDITIONS FOR USE Definitions And Interpretations; Interpretative Statements Re: Warnings On Drugs And Devices For OTC Sale

USE, DIRECTIONS 107.20 DIRECTIONS FOR USE Labeling; Infant Formula

USE, DIRECTIONS 201.3 DRUGS; ADEQUATE DIRECTIONS FOR USE Labeling

USE, DIRECTIONS 250.12 STRAMONIUM PREPARATIONS LABELED WITH DIRECTIONS FOR USE IN SELF-MEDICATION REGARDED AS MISBRANDED Drugs Regarded As Misbranded; Specific Requirements For Specific Human Drugs

USE, DIRECTIONS 801.5 MEDICAL DEVICES; ADEQUATE DIRECTIONS FOR USE General Labeling Provisions; Labeling

USE, EMERGENCY 312.36 EMERGENCY USE OF AN INVESTIGATIONAL NEW DRUG Investigational New Drug Application

USE, EXTRALABEL 5.500 ISSUANCE OF FEDERAL REGISTER DOCUMENTS PERTAINING TO THE DETERMINATION OF SAFE LEVELS, NOTICE OF NEED FOR DEVELOPMENT OF AN ANALYTICAL METHOD, AND PROHIBITION OF CERTAIN EXTRALABEL DRUG USE Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization

USE, EXTRALABEL 530.10 PROVISION PERMITTING EXTRALABEL USE OF ANIMAL DRUGS Extralabel Drug Use In Animals

USE, EXTRALABEL 530.13 EXTRALABEL USE FROM COMPOUNDING OF APPROVED NEW ANIMAL AND HUMAN DRUGS Extralabel Drug Use In Animals

Extralabel Drug Use In Animals

USE, EXTRALABEL 530.41 DRUGS PROHIBITED FOR EXTRALABEL USE IN ANIMALS Extralabel Drug Use In Animals

USE, HUMAN 110.110 NATURAL OR UNAVOIDABLE DEFECTS IN FOOD FOR HUMAN USE THAT PRESENT NO HEALTH HAZARD Defect Action Levels; Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food

USE, HUMAN 201.20 DECLARATION OF PRESENCE OF FD&C YELLOW NO. 5 AND/OR FD&C YELLOW NO. 6 IN CERTAIN DRUGS FOR HUMAN USE General Labeling Provisions; Labeling

USE, HUMAN 201.21 DECLARATION OF PRESENCE OF PHENYLALANINE AS A COMPONENT OF ASPARTAME IN OVER-THE-COUNTER AND PRESCRIPTION DRUGS FOR HUMAN USE General Labeling Provisions; Labeling

USE, HUMAN 201.100 PRESCRIPTION DRUGS FOR HUMAN USE Exemptions From Adequate Directions For Use; Labeling

USE, HUMAN 201.305 ISOPROTERENOL INHALATION PREPARATIONS (PRESSURIZED AEROSOLS, NEBULIZERS, POWDERS) FOR HUMAN USE; WARNINGS Specific Labeling Requirements For Specific Drug Products; Labeling

USE, HUMAN 201.316 DRUGS WITH THYROID HORMONE ACTIVITY FOR HUMAN USE; REQUIRED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling

USE, HUMAN 201.317 DIGITALIS AND RELATED CARDIOTONIC DRUGS FOR HUMAN USE IN ORAL DOSAGE FORMS; REQUIRED WARNING Specific Labeling Requirements For Specific Drug Products; Labeling

USE, HUMAN 250.100 AMYL NITRITE INHALANT AS A PRESCRIPTION DRUG FOR HUMAN USE New Drug Or Prescription Status Of Specific Drugs; Specific Requirements For Specific Human Drugs

USE, HUMAN 250.102 DRUG PREPARATIONS INTENDED FOR HUMAN USE CONTAINING CERTAIN “CORONARY VASODILATORS” New Drug Or Prescription Status Of Specific Drugs; Specific Requirements For Specific Human Drugs

USE, HUMAN 310.305 RECORDS AND REPORTS CONTAINING ADVERSE DRUG EXPERIENCES ON MARKETED PRESCRIPTION DRUGS FOR HUMAN USE WITHOUT APPROVED NEW DRUG APPLICATIONS Records And Reports; New Drugs

USE, HUMAN 310.530 TOPICALLY APPLIED HORMONE-CONTAINING DRUG PRODUCTS FOR OVERTHE-COUNTER HUMAN USE Requirements For Specific New Drugs Or Devices; New Drugs

USE, HUMAN 310.533 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OTC FOR HUMAN USE AS AN ANTICHOLINERGIC IN COUGH-COLD DRUG PRODUCTS Requirements For Specific New Drugs Or Devices; New Drugs

USE, HUMAN 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

USE, HUMAN 310.543 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OTC FOR HUMAN USE IN EXOCRINE PANCREATIC INSUFFICIENCY Requirements For Specific New Drugs Or Devices; New Drugs

USE, INDICATIONS FOR 814.110 NEW INDICATIONS FOR USE Humanitarian Use Devices; Premarket Approval Of Medical Devices

USE, INTERNAL 357.810 ACTIVE INGREDIENTS FOR DEODORANT DRUG PRODUCTS FOR INTERNAL USE Deodorant Drug Products For Internal Use; Miscellaneous Internal Drug Products For Over-the-counter Human Use

USE, INTERNAL 357.850 LABELING OF DEODORANT DRUG PRODUCTS FOR INTERNAL USE Deodorant Drug Products For Internal Use; Miscellaneous Internal Drug Products For Over-the-counter Human Use

USE, INVESTIGATIONAL 5.101 TERMINATION OF EXEMPTIONS FOR NEW DRUGS FOR INVESTIGATIONAL USE IN HUMAN BEINGS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization

USE, INVESTIGATIONAL 5.505 TERMINATION OF EXEMPTIONS FOR NEW DRUGS FOR INVESTIGATIONAL USE IN ANIMALS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization

USE, INVESTIGATIONAL 312.160 DRUGS FOR INVESTIGATIONAL USE IN LABORATORY RESEARCH ANIMALS OR IN VITRO TESTS Drugs For Investigational Use In Laboratory Research Animals Or In Vitro Tests; Investigational New Drug Application

USE LOG 211.182 EQUIPMENT CLEANING AND USE LOG

Applications For FDA Approval To Market A New Drug

USE OF REFERENCE PANELS 610.44 USE OF REFERENCE PANELS BY MANUFACTURERS OF TEST KITS Testing Requirements For Communicable Disease Agents; General Biological Products Standards

USE, REPEATED 177.2600 RUBBER ARTICLES INTENDED FOR REPEATED USE Substances For Use Only As Components Of Articles Intended For Repeated Use; Indirect Food Additives: Polymers

USE, RESEARCH 201.125 DRUGS FOR USE IN TEACHING, LAW ENFORCEMENT, RESEARCH, AND ANALYSIS Exemptions From Adequate Directions For Use; Labeling

USE, RESEARCH 201.129 DRUGS; EXEMPTION FOR RADIOACTIVE DRUGS FOR RESEARCH USE Exemptions From Adequate Directions For Use; Labeling

USE, RESEARCH 801.125 MEDICAL DEVICES FOR USE IN TEACHING, LAW ENFORCEMENT, RESEARCH, AND ANALYSIS Exemptions From Adequate Directions For Use; Labeling

USE, RESTRICTIONS ON 610.42 RESTRICTIONS ON USE FOR FURTHER MANUFACTURE OF MEDICAL DEVICES Testing Requirements For Communicable Disease Agents; General Biological Products Standards

USE, SAFE 314.520 APPROVAL WITH RESTRICTIONS TO ASSURE SAFE USE Accelerated Approval Of New Drugs; Applications For FDA Approval To Market A New Drug

USE, SAFE 601.42 APPROVAL WITH RESTRICTIONS TO ASSURE SAFE USE Accelerated Approval Of Biological Products; Licensing

USE OF TERMS 500.52 USE OF TERMS SUCH AS “TONIC,” “TONE,” “TONER,” OR “CONDITIONER” IN THE LABELING OF PREPARATIONS INTENDED FOR USE IN OR ON ANIMALS Animal Drug Labeling Requirements; General

USE, TREATMENT 312.34 TREATMENT USE OF AN INVESTIGATIONAL NEW DRUG Investigational New Drug Application

USE, TREATMENT 312.35 SUBMISSIONS FOR TREATMENT USE Investigational New Drug Application

USE, TREATMENT 316.40 TREATMENT USE OF A DESIGNATED ORPHAN DRUG Orphan Drugs

USE, TREATMENT 812.36 TREATMENT USE OF AN INVESTIGATIONAL DEVICE Investigational Device Exemptions

USER FACILITIES 803.10 GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS Medical Device Reporting

USER FACILITIES 803.30 INDIVIDUAL ADVERSE EVENT REPORTS; USER FACILITIES Medical Device Reporting

USER LABELING 801.430 USER LABELING FOR MENSTRUAL TAMPONS Special Requirements For Specific Devices; Labeling

USER LABELING 801.435 USER LABELING FOR LATEX CONDOMS Special Requirements For Specific Devices; Labeling

USER LABELING 801.437 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER Special Requirements For Specific Devices; Labeling

USER NOTIFICATION 1002.3 NOTIFICATION TO USER OF PERFORMANCE AND TECHNICAL DATA General Provisions; Records and Reports

USES, EXTRALABEL 530.25 ORDERS PROHIBITING EXTRALABEL USES FOR DRUGS IN FOODPRODUCING ANIMALS Extralabel Drug Use In Animals

USES, INTENDED 201.128 MEANING OF “INTENDED USES” Exemptions From Adequate Directions For Use; Labeling

USES, INTENDED 801.4 MEANING OF “INTENDED USES” General Labeling Provisions; Labeling

UTENSILS 110.40 EQUIPMENT AND UTENSILS Equipment; Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food

UTENSILS 1250.44 DRINKING UTENSILS AND TOILET ARTICLES Equipment And Operation Of Land And Air Conveyances; Interstate Conveyance Sanitation

UTERINE MONITOR 884.2720 EXTERNAL UTERINE CONTRACTION MONITOR AND ACCESSORIES Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices

UTERINE MONITOR 884.2730 HOME UTERINE ACTIVITY MONITOR Obstetrical And Gynecological Monitoring Devices; Obstetrical And Gynecological Devices

UTEROTUBAL 884.1300 UTEROTUBAL CARBON DIOXIDE INSUFFLATOR AND ACCESSORIES Obstetrical And Gynecological Diagnostic Devices; Obstetrical And Gynecological Devices