ABSTRACT
N-BUTANE 184.1165 N-BUTANE AND ISO-BUTANE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
N-BUTYL CHLORIDE 520.260 N-BUTYL CHLORIDE CAPSULES Oral Dosage Form New Animal Drugs
NACMC 872.3500 POLYVINYLMETHYLETHER MALEIC ANHYDRIDE (PVM-MA), ACID COPOLYMER, AND CARBOXYMETHYLCELLULOSE SODIUM (NACMC) DENTURE ADHESIVE Prosthetic Devices; Dental Devices
NAILBITING 310.536 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OVER-THECOUNTER (OTC) FOR USE AS A NAILBITING OR THUMBSUCKING DETERRENT Requirements For Specific New Drugs Or Devices; New Drugs
NALORPHINE HYDROCHLORIDE 522.1452 NALORPHINE HYDROCHLORIDE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
NALOXONE HYDROCHLORIDE 522.1462 NALOXONE HYDROCHLORIDE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
NALTREXONE 522.1465 NALTREXONE HYDROCHLORIDE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
NAME 101.5 FOOD, NAME AND PLACE OF BUSINESS OF MANUFACTURER, PACKER, OR DISTRIBUTOR General Provisions; Food Labeling
NAME 201.1 DRUGS; NAME AND PLACE OF BUSINESS OF MANUFACTURER, PACKER OR DISTRIBUTOR General Labeling Provisions; Labeling
NAME 501.5 ANIMAL FOOD; NAME AND PLACE OF BUSINESS OF MANUFACTURER, PACKER, OR DISTRIBUTOR General Provisions; Animal Food Labeling
NAME 610.64 NAME OF SELLING AGENT OR DISTRIBUTOR Labeling Standards; General Biological Products Standards
NAME 701.12 NAME AND PLACE OF BUSINESS OF MANUFACTURER, PACKER, OR DISTRIBUTOR Package Form; Cosmetic Labeling
NAME 801.1 MEDICAL DEVICES; NAME AND PLACE OF BUSINESS OF MANUFACTURER, PACKER OR DISTRIBUTOR General Labeling Provisions; Labeling
NAME, COMPENDIAL 299.5 DRUGS; COMPENDIAL NAME General Provisions; Drugs; Official Names And Established Names
NAME, PROPER 610.62 PROPER NAME; PACKAGE LABEL; LEGIBLE TYPE Labeling Standards; General Biological Products Standards
NAMES 20.32 DISCLOSURE OF FDA EMPLOYEE NAMES General Policy; Public Information
NAMES 20.119 LISTS OF NAMES AND ADDRESSES Availability Of Specific Categories Of Records; Public Information
NAMES 510.600 NAMES, ADDRESSES, AND DRUG LABELER CODES OF SPONSORS OF APPROVED APPLICATIONS Sponsors Of Approved Applications; New Animal Drugs
NAMES, COLLECTIVE 501.110 ANIMAL FEED LABELING; COLLECTIVE NAMES FOR FEED INGREDIENTS Exemptions From Animal Food Labeling Requirements; Animal Food Labeling
NAMES, DRUGS 299.4 ESTABLISHED NAMES FOR DRUGS General Provisions; Drugs; Official Names And Established Names
NAMES, INGREDIENT 701.30 INGREDIENT NAMES ESTABLISHED FOR COSMETIC INGREDIENT LABELING Labeling Of Specific Ingredients; Cosmetic Labeling
NAPHTHA 172.250 PETROLEUM NAPHTHA Coatings, Films And Related Substances; Food Additives Permitted For Direct Addition To Food For Human Consumption
NAPHTHALENE SULPHONATES 172.824 SODIUM MONO-AND DIMETHYL NAPHTHALENE SULFONATES Multipurpose Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NAPHTHALENEDIYLCARBONYL 177.1637 POLY(OXY-1,2-ETHANEDIYLOXYCARBONYL-2,6NAPHTHALENEDIYLCARBONYL) RESINS Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
NAPHTHENATE, COPPER 524.463 COPPER NAPHTHENATE SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
Specific Tolerances For Residues Of New Animal Drugs, Tolerances For Residues Of New Animal Drugs In Food
NARASIN 558.363 NARASIN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NARCOTIC 1304.31 REPORTS FROM MANUFACTURERS IMPORTING NARCOTIC RAW MATERIAL Reports; Records And Reports Of Registrants
NARCOTIC DRUGS 1306.07 ADMINISTERING OR DISPENSING OF NARCOTIC DRUGS General Information; Prescriptions
NARCOTIC TREATMENT 1301.72 PHYSICAL SECURITY CONTROLS FOR NON-PRACTITIONERS; NARCOTIC TREATMENT PROGRAMS AND COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS; STORAGE AREAS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NARCOTIC TREATMENT 1301.73 PHYSICAL SECURITY CONTROLS FOR NON-PRACTITIONERS; COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS; MANUFACTURING AND COMPOUNDING AREAS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NARCOTIC TREATMENT 1301.74 OTHER SECURITY CONTROLS FOR NON-PRACTITIONERS; NARCOTIC TREATMENT PROGRAMS AND COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NARCOTICS 1304.25 RECORDS FOR TREATMENT PROGRAMS WHICH COMPOUND NARCOTICS FOR TREATMENT PROGRAMS AND OTHER LOCATIONS Continuing Records; Records And Reports Of Registrants
NASAL CANNULA 868.5340 NASAL OXYGEN CANNULA Therapeutic Devices; Anesthesiology Devices
NASAL CATHETER 868.5350 NASAL OXYGEN CATHETER Therapeutic Devices; Anesthesiology Devices
NASAL DECONGESTANT 341.20 NASAL DECONGESTANT ACTIVE INGREDIENTS Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For OTC Human Use
NASAL DECONGESTANT 341.80 LABELING NASAL DECONGESTANT DRUG PRODUCTS Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For OTC Human Use
NASAL DILATOR 874.3900 NASAL DILATOR Prosthetic Devices; Ear, Nose, And Throat Devices
NASAL IRRIGATOR 874.5550 POWERED NASAL IRRIGATOR Therapeutic Devices; Ear, Nose, And Throat Devices
NASAL SPLINT 874.5800 EXTERNAL NASAL SPLINT Therapeutic Devices; Ear, Nose, And Throat Devices
NASOPHARYNGEAL 868.5100 NASOPHARYNGEAL AIRWAY Therapeutic Devices; Anesthesiology Devices
NASOPHARYNGEAL 874.4175 NASOPHARYNGEAL CATHETER Surgical Devices; Ear, Nose, And Throat Devices
NASOPHARYNGEAL 882.1340 NASOPHARYNGEAL ELECTRODE Neurological Diagnostic Devices; Neurological Devices
NASOPHARYNGOSCOPE 874.4760 NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES Surgical Devices; Ear, Nose, And Throat Devices
NATAMYCIN 172.155 NATAMYCIN (PIMARICIN) Food Preservatives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NATIONAL ARCHIVES 21.31 RECORDS STORED BY THE NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Requirements For Specific Categories Of Records; Protection Of Privacy
NATIONAL DRUG CODE 201.2 DRUGS AND DEVICES; NATIONAL DRUG CODE NUMBERS General Labeling Provisions; Labeling
NATIONAL DRUG CONTROL 1401.2 THE OFFICE OF NATIONAL DRUG CONTROL POLICY - ORGANIZATION AND FUNCTIONS Public Availability Of Information
NATIONAL LAB ACCREDITATION 5.303 ESTABLISHING STANDARDS AND APPROVING ACCREDITING BODIES UNDER THE NATIONAL LABORATORY ACCREDITATION PROGRAM Foods And Cosmetics; Redelegations Of Authority; Delegations Of Authority And Organization
NATIONAL TECH. INFO 20.50 AVAILABILITY OF RECORDS AT NATIONAL TECHNICAL INFORMATION SERVICE Procedures And Fees; Public Information
NATIVE AMERICAN CHURCH 1307.31 NATIVE AMERICAN CHURCH
Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NATURAL DEFECTS 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
NATURAL EXTRACTIVES 182.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE), AND NATURAL EXTRACTIVES (INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
NATURAL EXTRACTIVES 182.40 NATURAL EXTRACTIVES (SOLVENT-FREE) USED IN CONJUNCTION WITH SPICES, SEASONINGS, AND FLAVORINGS General Provisions; Substances Generally Recognized As Safe
NATURAL EXTRACTIVES 582.20 ESSENTIAL OILS, OLEORESINS (SOLVENT-FREE), AND NATURAL EXTRACTIVES (INCLUDING DISTILLATES) General Provisions; Substances Generally Recognized As Safe
NATURAL EXTRACTIVES 582.40 NATURAL EXTRACTIVES (SOLVENT-FREE) USED IN CONJUNCTION WITH SPICES, SEASONINGS, AND FLAVORINGS General Provisions; Substances Generally Recognized As Safe
NATURAL EXTRACTS 182.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
NATURAL EXTRACTS 582.50 CERTAIN OTHER SPICES, SEASONINGS, ESSENTIAL OILS, OLEORESINS, AND NATURAL EXTRACTS General Provisions; Substances Generally Recognized As Safe
NATURAL FLAVORING 172.510 NATURAL FLAVORING SUBSTANCES AND NATURAL SUBSTANCES USED IN CONJUNCTION WITH FLAVORS Flavoring Agents And Related Substances; Food Additives Permitted For Direct Addition To Food For Human Consumption
NATURAL RUBBER 801.437 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER Special Requirements For Specific Devices; Labeling
NATURAL SEASONINGS 182.10 SPICES AND OTHER NATURAL SEASONINGS AND FLAVORINGS General Provisions; Substances Generally Recognized As Safe
NATURAL SEASONINGS 582.10 SPICES AND OTHER NATURAL SEASONINGS AND FLAVORINGS General Provisions; Substances Generally Recognized As Safe
NATURAL SILK SUTURE 878.5030 NATURAL NONABSORBABLE SILK SURGICAL SUTURE Surgical Devices; General And Plastic Surgery Devices
NATURAL SUBSTANCES 582.30 NATURAL SUBSTANCES USED IN CONJUNCTION WITH SPICES AND OTHER NATURAL SEASONINGS AND FLAVORINGS General Provisions; Substances Generally Recognized As Safe
ND:YAG LASER 886.4392 ND:YAG LASER FOR POSTERIOR CAPSULOTOMY AND PERIPHERAL IRIDECTOMY Surgical Devices; Ophthalmic Devices
NDA 330.11 NDA DEVIATIONS FROM APPLICABLE MONOGRAPH Administrative Procedures; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
NDC 201.2 DRUGS AND DEVICES; NATIONAL DRUG CODE NUMBERS General Labeling Provisions; Labeling
NDC 607.35 NOTIFICATION OF REGISTRANT; BLOOD PRODUCT ESTABLISHMENT REGISTRATION NUMBER AND NDC LABELER CODE Procedures For Domestic Blood Product Establishments; Establishment Registratn+product Listing, Manufacturers Human Blood/b.products
NDGA 189.165 NORDIHYDORGUAIARETIC ACID (NDGA) Substances Generally Prohibited From Direct Addition Or Use As Human Food; Substances Prohibited From Use In Human Food
NEARPOINT RULER 886.1790 NEARPOINT RULER Diagnostic Devices; Ophthalmic Devices
NEBRASKA 808.77 NEBRASKA Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
NEBULIZER 868.5630 NEBULIZER Therapeutic Devices; Anesthesiology Devices
NEBULIZER 868.5640 MEDICINAL NONVENTILATORY NEBULIZER (ATOMIZER) Therapeutic Devices; Anesthesiology Devices
NEBULIZERS 201.305 ISOPROTERENOL INHALATION PREPARATIONS (PRESSURIZED AEROSOLS, NEBULIZERS, POWDERS) FOR HUMAN USE; WARNINGS Specific Labeling Requirements For Specific Drug Products; Labeling
NEED, PERMIT 108.5 DETERMINATION OF THE NEED FOR A PERMIT General Provisions; Emergency Permit Control
NEEDLE 868.5090 EMERGENCY AIRWAY NEEDLE Therapeutic Devices; Anesthesiology Devices
Surgical Devices; Dental Devices
NEEDLE 880.5570 HYPODERMIC SINGLE LUMEN NEEDLE General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NEEDLE 880.5580 ACUPUNCTURE NEEDLE General Hospital And Personal Use Devices
NEEDLE 880.6920 SYRINGE NEEDLE INTRODUCER General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
NEEDLE 882.1350 NEEDLE ELECTRODE Neurological Diagnostic Devices; Neurological Devices
NEEDLE 882.4650 NEUROSURGICAL SUTURE NEEDLE Neurological Surgical Devices; Neurological Devices
NEEDLE 890.1385 DIAGNOSTIC ELECTROMYOGRAPH NEEDLE ELECTRODE Physical Medicine Diagnostic Devices; Physical Medicine Devices
NEEDLE-TYPE EPILATOR 878.5350 NEEDLE-TYPE EPILATOR Therapeutic Devices; General And Plastic Surgery Devices
NEEDLES, REPRODUCTION 884.6100 ASSISTED REPRODUCTION NEEDLES Assisted Reproduction Devices; Obstetrical And Gynecological Devices
NEGATIVE 868.5935 EXTERNAL NEGATIVE PRESSURE VENTILATOR Therapeutic Devices; Anesthesiology Devices
NEISSERIA SPP. 866.2410 CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SPP. Microbiology Devices; Immunology And Microbiology Devices
NEISSERIA SPP. 866.3390 NEISSERIA SPP. DIRECT SEROLOGICAL TEST REAGENTS Serological Reagents; Immunology And Microbiology Devices
NEOMYCIN 520.1921 PROCHLORPERAZINE, ISOPROPAMIDE, WITH NEOMYCIN SUSTAINEDRELEASE CAPSULES Oral Dosage Form New Animal Drugs
NEOMYCIN 524.1484h NEOMYCIN, PENICILLIN, POLYMIXIN, HYDROCORTISONE SUSPENSION Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN 524.1600a NYSTATIN, NEOMYCIN, THIOSTREPTON, AND TRIAMCINOLONE ACETONIDE OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN 524.1600b NYSTATIN, NEOMYCIN, THIOSTREPTON, AND TRIAMCINOLONE ACETONIDE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN 556.430 NEOMYCIN Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
NEOMYCIN SULFATE 520.82b AMINOPROPAZINE FUMARATE, NEOMYCIN SULFATE TABLETS Oral Dosage Form New Animal Drugs
NEOMYCIN SULFATE 520.1484 NEOMYCIN SULFATE SOLUBLE POWDER Oral Dosage Form New Animal Drug Applications
NEOMYCIN SULFATE 520.1485 NEOMYCIN SULFATE ORAL SOLUTION Oral Dosage Form New Animal Drugs
NEOMYCIN SULFATE 522.1484 NEOMYCIN SULFATE STERILE SOLUTION Implantation Or Injectable Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.154 BACITRACIN OR BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMIXIN B SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.155 BACITRACIN ZINC-POLYMIXIN B SULFATE-NEOMYCIN SULFATEHYDROCORTISONE OR HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.960 FLUMETHASONE, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTION Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.981c FLUOCINOLONE ACETONIDE, NEOMYCIN SULFATE CREAM Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.1484 NEOMYCIN SULFATE OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.1880 PREDNISOLONE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.1881b PREDNISOLONE ACETATE-NEOMYCIN SULFATE STERILE SUSPENSION Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 524.1883 PREDNISOLONE SODIUM PHOSPHATE-NEOMYCIN SULFATE OPHTHALMIC OINTMENT Ophthalmic And Topical Dosage Form New Animal Drugs
NEOMYCIN SULFATE 558.364 NEOMYCIN SULFATE New Animal Drugs For Use In Animal Feeds
General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NEONATAL 880.5400 NEONATAL INCUBATOR General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NEONATAL 880.5410 NEONATAL TRANSPORT INCUBATOR General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NEONATAL 880.5700 NEONATAL PHOTOTHERAPY UNIT General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NEONATE 862.1113 BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NEOSTIGMINE 522.1503 NEOSTIGMINE METHYLSULFATE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs
NEPA PLANNING 25.10 POLICIES AND NEPA PLANNING General Provisions; Environmental Impact Considerations
NEPHELOMETER 862.2700 NEPHELOMETER FOR CLINICAL USE Clinical Laboratory Instruments; Clinical Chemistry And Clinical Toxicology Devices
NEQUINATE 556.440 NEQUINATE Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
NEQUINATE 558.365 NEQUINATE Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NERVE 868.2775 ELECTRICAL PERIPHERAL NERVE STIMULATOR Monitoring Devices; Anesthesiology Devices
NERVE 870.3850 CAROTID SINUS NERVE STIMULATOR Cardiovascular Prosthetic Devices; Cardiovascular Devices
NERVE 874.1820 SURGICAL NERVE STIMULATOR/LOCATOR Diagnostic Devices; Ear, Nose, And Throat Devices
NERVE 882.1550 NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE Neurological Diagnostic Devices; Neurological Devices
NERVE 882.5275 NERVE CUFF Neurological Therapeutic Devices; Neurological Devices
NERVE 882.5830 IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR Neurological Therapeutic Devices; Neurological Devices
NERVE 882.5870 IMPLANTED PERIPHERAL NERVE STIMULATOR FOR PAIN RELIEF Neurological Therapeutic Devices; Neurological Devices
NERVE 882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF Neurological Therapeutic Devices; Neurological Devices
NERVOUS SYSTEM 882.5550 CENTRAL NERVOUS SYSTEM FLUID SHUNT AND COMPONENTS Neurological Therapeutic Devices; Neurological Devices
NET QUANTITY 101.105 DECLARATION OF NET QUANTITY OF CONTENTS WHEN EXEMPT Exemptions From Food Labeling Requirements; Food Labeling
NET QUANTITY 201.51 DECLARATION OF NET QUANTITY OF CONTENTS Labeling Requirements For Prescription Drugs And/or Insulin; Labeling
NET QUANTITY 201.62 DECLARATION OF NET QUANTITY OF CONTENTS Labeling Requirements For Over-the-counter Drugs; Labeling
NET QUANTITY 501.105 DECLARATION OF NET QUANTITY OF CONTENTS WHEN EXEMPT Exemptions From Animal Food Labeling Requirements; Animal Food Labeling
NET QUANTITY 701.13 DECLARATION OF NET QUANTITY OF CONTENTS Package Form; Cosmetic Labeling
NET QUANTITY 801.62 DECLARATION OF NET QUANTITY OF CONTENTS Labeling Requirements For Over-the-counter Devices; Labeling
NEUFCHATEL CHEESE 133.162 NEUFCHATEL CHEESE Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
NEUFCHATEL CHEESE 133.178 PASTEURIZED NEUFCHATEL CHEESE SPREAD WITH OTHER FOODS Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
NEURAL TUBE 101.79 HEALTH CLAIMS: FOLATE AND NEURAL TUBE DEFECTS Food Labeling
NEUROLEPTIC 862.3645 NEUROLEPTIC DRUGS RADIORECEPTOR ASSAY TEST SYSTEM Clinical Toxicology Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NEUROLOGICAL 882.1480 NEUROLOGICAL ENDOSCOPE Neurological Diagnostic Devices; Neurological Devices
NEUROMUSCULAR 882.5810 EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
Neurological Surgical Devices; Neurological Devices
NEUROSURGICAL 882.4125 NEUROSURGICAL CHAIR Neurological Surgical Devices; Neurological Devices
NEUROSURGICAL 882.4440 NEUROSURGICAL HEADRESTS Neurological Surgical Devices; Neurological Devices
NEUROSURGICAL 882.4460 NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) Neurological Surgical Devices; Neurological Devices
NEUROSURGICAL 882.4535 NONPOWERED NEUROSURGICAL INSTRUMENT Neurological Surgical Devices; Neurological Devices
NEUROSURGICAL 882.4650 NEUROSURGICAL SUTURE NEEDLE Neurological Surgical Devices; Neurological Devices
NEUTRON 892.5300 MEDICAL NEUTRON RADIATION THERAPY SYSTEM Therapeutic Devices; Radiology Devices
NEW ANIMAL DRUG 510.455 NEW ANIMAL DRUG REQUIREMENTS REGARDING FREE-CHOICE ADMINISTRATION IN FEEDS Requirements For Specific New Animal Drugs; New Animal Drugs
NEW ANIMAL DRUG 514.12 CONFIDENTIALITY OF DATA AND INFORMATION IN AN INVESTIGATIONAL NEW ANIMAL DRUG NOTICE General Provisions; New Animal Drug Applications
NEW ANIMAL DRUG 558.5 NEW ANIMAL DRUG REQUIREMENTS FOR LIQUID TYPE B FEEDS General Provisions; New Animal Drugs For Use In Animal Feeds
NEW ANIMAL DRUG 514.11 CONFIDENTIALITY OF DATA AND INFORMATION IN A NEW ANIMAL DRUG APPLICATION APPLICATION FILE
General Provisions; New Animal Drug Applications NEW ANIMAL DRUG 5.501 APPROVAL OF NEW ANIMAL DRUG APPLICATIONS AND THEIR
APPLICATIONS SUPPLEMENTS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW ANIMAL DRUG 5.503 SUBMISSION OF AND EFFECTIVE APPROVAL DATES FOR ABBREVIATED APPLICATIONS NEW ANIMAL DRUG APPLICATIONS
Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW ANIMAL DRUG 514.8 SUPPLEMENTAL NEW ANIMAL DRUG APPLICATIONS APPLICATIONS General Provisions; New Animal Drug Applications
NEW ANIMAL DRUGS 5.502 ISSUANCE OF NOTICES, PROPOSALS, AND ORDERS RELATING TO NEW ANIMAL DRUGS AND MEDICATED FEED MILL LICENSE APPLICATIONS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW ANIMAL DRUGS 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
NEW ANIMAL DRUGS 201.115 NEW DRUGS OR NEW ANIMAL DRUGS Exemptions From Adequate Directions For Use; Labeling
NEW ANIMAL DRUGS 510.7 CONSIGNEES OF NEW ANIMAL DRUGS FOR USE IN THE MANUFACTURE OF ANIMAL FEED General Provisions; New Animal Drugs
NEW ANIMAL DRUGS 510.300 RECORDS AND REPORTS CONCERNING EXPERIENCE WITH NEW ANIMAL DRUGS FOR WHICH AN APPROVED APPLICATION IS IN EFFECT Records And Reports; New Animal Drugs
NEW ANIMAL DRUGS 510.301 RECORDS AND REPORTS CONCERNING EXPERIENCE WITH ANIMAL FEEDS BEARING OR CONTAINING NEW ANIMAL DRUGS FOR WHICH AN APPROVED MEDICATED FEED MILL LICENSE IS IN EFFECT Records And Reports; New Animal Drugs
NEW ANIMAL DRUGS 510.305 MAINTENANCE OF COPIES OF APPROVED MEDICATED FEED MILL LICENSES TO MANUFACTURE ANIMAL FEED BEARING OR CONTAINING NEW ANIMAL DRUGS Records And Reports; New Animal Drugs
NEW ANIMAL DRUGS 510.515 ANIMAL FEEDS BEARING OR CONTAINING NEW ANIMAL DRUGS SUBJECT TO THE PROVISIONS OF SECTION 512(N) OF THE ACT Animal Use Exemptions From Certification And Labeling Requirements; New Animal Drugs
NEW ANIMAL DRUGS 511.1 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE EXEMPT FROM SECTION 512(A) New Animal Drugs For Investigational Use
NEW ANIMAL DRUGS 514.2 APPLICATIONS FOR ANIMAL FEEDS BEARING OR CONTAINING NEW ANIMAL DRUGS General Provisions; New Animal Drug Applications
APPROVED HUMAN DRUGS Extralabel Drug Use In Animals
NEW ANIMAL DRUGS 556.1 GENERAL CONSIDERATIONS; TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD General Provisions; Tolerances For Residues Of New Animal Drugs In Food
NEW DEVICES 860.134 PROCEDURES FOR “NEW DEVICES” UNDER SECTION 513(F) OF THE ACT AND RECLASSIFICATION OF CERTAIN DEVICES Reclassification; Medical Device Classification Procedures
NEW DRUG 20.117 NEW DRUG INFORMATION Availability Of Specific Categories Of Records; Public Information
NEW DRUG 310.6 APPLICABILITY OF “NEW DRUG” OR SAFETY/EFFECTIVENESS FINDINGS IN DRUG EFFICACY STUDY IMPLEMENTATION NOTICES AND NOTICES OF OPPORTUNITY FOR HEARING TO IDENTICAL, RELATED, AND SIMILAR DRUG PRODUCTS General Provisions; New Drugs
NEW DRUG 310.100 NEW DRUG STATUS OPINIONS; STATEMENT OF POLICY Specific Administrative Rulings And Decisions; New Drugs
NEW DRUG 310.103 NEW DRUG SUBSTANCES INTENDED FOR HYPERSENSITIVITY TESTING Specific Administrative Rulings And Decisions; New Drugs
NEW DRUG 310.502 CERTAIN DRUGS ACCORDED NEW DRUG STATUS THROUGH RULEMAKING PROCEDURES Requirements For Specific New Drugs Or Devices; New Drugs
NEW DRUG 312.6 LABELING OF AN INVESTIGATIONAL NEW DRUG Investigational New Drug Application
NEW DRUG 312.34 TREATMENT USE OF AN INVESTIGATIONAL NEW DRUG Investigational New Drug Application
NEW DRUG 312.36 EMERGENCY USE OF AN INVESTIGATIONAL NEW DRUG Investigational New Drug Application
NEW DRUG 312.40 GENERAL REQUIREMENTS FOR USE OF AN INVESTIGATIONAL NEW DRUG IN A CLINICAL INVESTIGATION Investigational New Drug Application
NEW DRUG 314.108 NEW DRUG PRODUCT EXCLUSIVITY Applications For FDA Approval To Market A New Drug
NEW DRUG 601.50 CONFIDENTIALITY OF DATA AND INFORMATION IN AN INVESTIGATIONAL NEW DRUG NOTICE FOR A BIOLOGICAL PRODUCT Confidentiality Of Information; Licensing
NEW DRUG APPLICATION 314.101 FILING AN APPLICATION AND RECEIVING AN ABBREVIATED NEW DRUG APPLICATION Applications For FDA Approval To Market A New Drug
NEW DRUG APPLICATION 314.127 REFUSAL TO APPROVE AN ABBREVIATED NEW DRUG APPLICATION Applications For FDA Approval To Market A New Drug
NEW DRUG APPLICATION 314.151 WITHDRAWAL OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION UNDER SECTION 505(J)(5) Applications For FDA Approval To Market A New Drug
NEW DRUG APPLICATION 314.152 NOTICE OF WITHDRAWAL OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION UNDER SECTION 505(J)(5) FDA Action On Applications; Applications For FDA Approval To Market A New Drug
NEW DRUG APPLICATION 314.153 SUSPENSION OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION FDA Action On Applications; Applications For FDA Approval To Market A New Drug
NEW DRUG APPLICATION 320.31 APPLICABILITY OF REQUIREMENTS REGARDING AN “INVESTIGATIONAL NEW DRUG APPLICATION” Procedures For Determining The Bioavailability Or Bioequivalence Of Drug Products; Bioavailability And Bioequivalence Requirements
NEW DRUG APPLICATIONS 5.103 APPROVAL OF NEW DRUG APPLICATIONS AND THEIR SUPPLEMENTS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW DRUG APPLICATIONS 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
NEW DRUG APPLICATIONS 5.106 SUBMISSION OF AND EFFECTIVE APPROVAL DATES FOR ABBREVIATED NEW DRUG APPLICATIONS AND CERTAIN NEW DRUG APPLICATIONS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW DRUG APPLICATIONS 310.201 EXEMPTION FOR CERTAIN DRUGS LIMITED BY NEW DRUG APPLICATIONS TO PRESCRIPTION SALE New Drugs Exempted From Prescription-dispensing Requirements; New Drugs
NEW DRUG APPLICATIONS 310.303 CONTINUATION OF LONG-TERM STUDIES, RECORDS, AND REPORTS ON CERTAIN DRUGS FOR WHICH NEW DRUG APPLICATIONS HAVE BEEN
MARKETED PRESCRIPTION DRUGS FOR HUMAN USE WITHOUT APPROVED NEW DRUG APPLICATIONS Records And Reports; New Drugs
NEW DRUGS 5.101 TERMINATION OF EXEMPTIONS FOR NEW DRUGS FOR INVESTIGATIONAL USE OF HUMAN BEINGS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW DRUGS 5.102 AUTHORITY TO APPROVE AND TO WITHDRAW APPROVAL OF A CHARGE FOR INVESTIGATIONAL NEW DRUGS Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW DRUGS 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
NEW DRUGS 5.505 TERMINATION OF EXEMPTIONS FOR NEW DRUGS FOR INVESTIGATIONAL USE IN ANIMALS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NEW DRUGS 70.10 COLOR ADDITIVES IN STANDARDIZED FOODS AND NEW DRUGS General Provisions; Color Additives
NEW DRUGS 201.115 NEW DRUGS OR NEW ANIMAL DRUGS Exemptions From Adequate Directions For Use; Labeling
NEW DRUGS 314.410 IMPORTS AND EXPORTS OF NEW DRUGS Miscellaneous Provisions; Applications For FDA Approval To Market A New Drug
NEW FORMULATIONS 106.120 NEW FORMULATIONS AND REFORMULATIONS Notification Requirements; Infant Formula Quality Control Procedures
NEW INDICATION 314.54 PROCEDURE FOR SUBMISSION OF AN APPLICATION REQUIRING INVESTIGATIONS FOR APPROVAL OF A NEW INDICATION FOR, OR OTHER CHANGE FROM, A LISTED DRUG Applications For FDA Approval To Market A New Drug
NEW INDICATIONS 814.110 NEW INDICATIONS FOR USE Humanitarian Use Devices; Premarket Approval Of Medical Devices
NEW JERSEY 808.80 NEW JERSEY Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
NEW MEXICO 808.81 NEW MEXICO Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
NEW RECORDS 20.24 PREPARATION OF NEW RECORDS General Policy; Public Information
NEW SYSTEMS 1.21 CHANGES IN SYSTEMS AND NEW SYSTEMS FDA Privacy Act Record Systems; Protection Of Privacy
NEW YORK 808.82 NEW YORK Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements
NIACIN 184.1530 NIACIN Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NIACIN 582.5530 NIACIN Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
NIACINAMIDE 184.1535 NIACINAMIDE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NIACINAMIDE 582.5535 NIACINAMIDE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
NIBS, CACAO 163.110 CACAO NIBS Requirements For Specific Standardized Cacao Products; Cacao Products
NICARBAZIN 556.445 NICARBAZIN Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
NICARBAZIN 558.366 NICARBAZIN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NICKEL 184.1537 NICKEL Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NICOTINAMIDE 172.315 NICOTINAMIDE-ASCORBIC ACID COMPLEX Special Dietary And Nutritional Additives; Food Additives Permitted For Direct
Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
NICOTINATE 172.310 ALUMINUM NICOTINATE Special Dietary And Nutritional Additive; Food Additives Permitted For Direct Addition To Food For Human Consumption
NIFURPIRINOL 529.1526 NIFURPIRINOL CAPSULES Certain Other Dosage Form New Animal Drugs
NIGHTTIME SLEEP-AID 338.10 NIGHTTIME SLEEP-AID ACTIVE INGREDIENTS Active Ingredients; Nighttime Sleep-aid Drug Products For Over-the-counter Human Use
NIGHTTIME SLEEP-AID 338.50 LABELING OF NIGHTTIME SLEEP-AID DRUG PRODUCTS Labeling; Nighttime Sleep-aid Drug Products For Over-the-counter Human Use
NIPPLE 880.5630 NIPPLE SHIELD General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NIPPLE 880.5640 LAMB FEEDING NIPPLE General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
NISIN PREPARATION 184.1538 NISIN PREPARATION Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NITARSONE 558.369 NITARSONE Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NITENPYRAM 520.1510 NITENPYRAM Oral Dosage Form New Animal Drugs
NITRATE, MICONAZOLE 524.1443 MICONAZOLE NITRATE CREAM; MICONAZOLE NITRATE LOTION; MICONAZOLE NITRATE SPRAY Ophthalmic And Topical Dosage Form New Animal Drugs
NITRATE, POTASSIUM 172.160 POTASSIUM NITRATE Food Preservatives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NITRATE, POTASSIUM 181.33 SODIUM NITRATE AND POTASSIUM NITRATE Specific Prior-sanctioned Food Ingredients; Prior-sanctioned Food Ingredients
NITRATE, SODIUM 172.170 SODIUM NITRATE Food Preservatives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NITRATE, SODIUM 176.320 SODIUM NITRATE-UREA COMPLEX Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives
NITRATE, SODIUM 181.33 SODIUM NITRATE AND POTASSIUM NITRATE Specific Prior-sanctioned Food Ingredients; Prior-sanctioned Food Ingredients
NITRATES 170.60 NITRITES AND/OR NITRATES IN CURING PREMIXES Specific Administrative Rulings And Decisions; Food Additives
NITRIC OXIDE 868.2380 NITRIC OXIDE ANALYZER Therapeutic Devices; Anesthesiology Devices
NITRIC OXIDE 868.5165 NITRIC OXIDE ADMINISTRATION APPARATUS Therapeutic Devices; Anesthesiology Devices
NITRILE 177.1480 NITRILE RUBBER MODIFIED ACRYLONITRILE-METHYL ACRYLATE COPOLYMERS Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
NITRITE 862.1510 NITRITE (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NITRITE, POTASSIUM 181.34 SODIUM NITRITE AND POTASSIUM NITRITE Specific Prior-sanctioned Food Ingredients; Prior-sanctioned Food Ingredients
NITRITE, SODIUM 172.175 SODIUM NITRITE Food Preservatives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NITRITE, SODIUM 172.177 SODIUM NITRITE USED IN PROCESSING SMOKED CHUB Food Preservatives; Food Additives Permitted For Direct Addition To Food For Human Consumption
NITRITE, SODIUM 181.34 SODIUM NITRITE AND POTASSIUM NITRITE Specific Prior-sanctioned Food Ingredients; Prior-sanctioned Food Ingredients
NITRITE, SODIUM 573.700 SODIUM NITRITE Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
NITRITES 170.60 NITRITES AND/OR NITRATES IN CURING PREMIXES Specific Administrative Rulings And Decisions; Food Additives
Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NITROGEN 582.1540 NITROGEN General Purpose Food Additives; Substances Generally Recognized As Safe
NITROGEN 862.1515 NITROGEN (AMINO-NITROGEN) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NITROGEN 862.1770 UREA NITROGEN TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NITROGEN 868.1690 NITROGEN GAS ANALYZER Diagnostic Devices; Anesthesiology Devices
NITROGEN DIOXIDE 868.2385 NITROGEN DIOXIDE ANALYZER Monitoring Devices; Anesthesiology Devices
NITROGLYCERIN 250.300 NITROGLYCERIN FOR HUMAN USE; PACKAGING AND WARNINGS Special Packaging Requirements; Specific Requirements For Specific Human Drugs
NITROMIDE 558.376 NITROMIDE AND SULFANITRAN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NITROTHIAZOLE 556.20 2-ACETYLAMINO-5-NITROTHIAZOLE Tolerances For Residues Of New Animal Drugs In Food
NITROUS OXIDE 184.1545 NITROUS OXIDE Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
NITROUS OXIDE 868.1700 NITROUS OXIDE GAS ANALYZER Diagnostic Devices; Anesthesiology Devices
NO RESIDUE 500.84 OPERATIONAL DEFINITION OF “NO RESIDUE” Regulation Of Carcinogenic Compounds Used In Food-producing Animals; General
NOCTURNAL MUSCLE CRAMPS 310.546 DRUG PRODUCTS CONTAINING ACTIVE INGREDIENTS OFFERED OTC FOR THE TREATMENT AND/OR PREVENTION OF NOCTURNAL LEG MUSCLE CRAMPS Requirements For Specific New Drugs Or Devices; New Drugs
NOISE GENERATOR 874.1120 ELECTRONIC NOISE GENERATOR FOR AUDIOMETRIC TESTING Diagnostic Devices; Ear, Nose, And Throat Devices
NOMINATIONS 14.82 NOMINATIONS OF VOTING MEMBERS OF STANDING ADVISORY COMMITTEES Members Of Advisory Committees; Public Hearing Before A Public Advisory Committee
NOMINATIONS 14.84 NOMINATIONS AND SELECTION OF NONVOTING MEMBERS OF STANDING TECHNICAL ADVISORY COMMITTEES Members Of Advisory Committees; Public Hearing Before A Public Advisory Committee
NON-ANTIFLATULENT 332.15 COMBINATION WITH NON-ANTIFLATULENT ACTIVE INGREDIENTS Active Ingredients; Antiflatulent Products For Over-the-counter Human Use
NON-FEDERAL 1403.26 NON-FEDERAL AUDIT Post-Award Requirements; Uniform Administrative Requirements For Grants And Coop. Agreements To State & Local Gov
NON-NARCOTIC 1312.30 SCHEDULE III, IV, AND V NON-NARCOTIC CONTROLLED SUBSTANCES REQUIRING AN IMPORT AND EXPORT PERMIT Exportation Of Controlled Substances; Importation And Exportation Of Controlled Substances
NON-PRACTITIONERS 1301.72 PHYSICAL SECURITY CONTROLS FOR NON-PRACTITIONERS; NARCOTIC TREATMENT PROGRAMS AND COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS; STORAGE AREAS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NON-PRACTITIONERS 1301.73 PHYSICAL SECURITY CONTROLS FOR NON-PRACTITIONERS; COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS; MANUFACTURING AND COMPOUNDING AREAS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NON-PRACTITIONERS; 1301.74 OTHER SECURITY CONTROLS FOR NON-PRACTITIONERS; NARCOTIC TREATMENT PROGRAMS AND COMPOUNDERS FOR NARCOTIC TREATMENT PROGRAMS Security Requirements; Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
NONABSORBABLE SUTURE 878.5000 NONABSORBABLE POLY(ETHYLENE TEREPHTHALATE) SURGICAL SUTURE Surgical Devices; General And Plastic Surgery Devices
NONABSORBABLE SUTURE 878.5010 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
Surgical Devices; General And Plastic Surgery Devices
NONALTERABLE 882.5330 PREFORMED NONALTERABLE CRANIOPLASTY PLATE Neurological Therapeutic Devices; Neurological Devices
NONANTACID 331.15 COMBINATION WITH NONANTACID ACTIVE INGREDIENTS Active Ingredients; Antacid Products For Over-the-counter (OTC) Human Use
NONCLINICAL LAB STUDY 58.130 CONDUCT OF A NONCLINICAL LABORATORY STUDY Protocol For And Conduct Of A Nonclinical Laboratory Study; Good Laboratory Practice For Nonclinical Laboratory Studies
NONCLINICAL LAB STUDY 58.185 REPORTING OF NONCLINICAL LABORATORY STUDY RESULTS Records And Reports; Good Laboratory Practice For Nonclinical Laboratory Studies
NONCOMPLYING 1005.3 IMPORTATION OF NONCOMPLYING GOODS PROHIBITED Importation Of Electronic Products
NONCONFORMING 820.90 NONCONFORMING PRODUCT Quality System Regulation
NONCONTINUOUS VENTILATOR 868.5905 NONCONTINUOUS VENTILATOR (IPPB) Therapeutic Devices; Anesthesiology Devices
NONFAT MILK 131.125 NONFAT DRY MILK Requirements For Specific Standardized Milk And Cream; Milk And Cream
NONFAT MILK 131.127 NONFAT DRY MILK FORTIFIED WITH VITAMINS A AND D Requirements For Specific Standardized Milk And Cream; Milk And Cream
NONFAT MILK 139.121 NONFAT MILK MACARONI PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NONFAT MILK 139.122 ENRICHED NONFAT MILK MACARONI PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NONFAT YOGURT 131.206 NONFAT YOGURT Requirements For Specific Standardized Milk And Cream; Milk And Cream
NONFOOD ANIMALS 530.30 EXTRALABEL DRUG USE IN NONFOOD ANIMALS Extralabel Drug Use In Animals
NONHUMAN 864.9160 BLOOD GROUP SUBSTANCES OF NONHUMAN ORIGIN FOR IN VITRO DIAGNOSTIC USE Products Used In Establishments That Manufacture Blood And Blood Products; Hematology And Pathology Devices
NONIMPLANTED 876.5310 NONIMPLANTED, PERIPHERAL ELECTRICAL CONTINENCE DEVICE Therapeutic Devices; Gastroenterology-urology Devices
NONIMPLANTED 876.5320 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE Therapeutic Devices; Gastroenterology-urology Devices
NONINFLATABLE SPLINT 878.3910 NONINFLATABLE EXTREMITY SPLINT Prosthetic Devices; General And Plastic Surgery Devices
NONINFRINGEMENT, PATENT 314.52 NOTICE OF CERTIFICATION OF INVALIDITY OR NONINFRINGEMENT OF A PATENT Applications For FDA Approval To Market A New Drug
NONINFRINGEMENT, PATENT 314.95 NOTICE OF CERTIFICATION OF INVALIDITY OR NONINFRINGEMENT OF A PATENT Applications For FDA Approval To Market A New Drug
NONINVASIVE 870.1130 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Cardiovascular Diagnostic Devices; Cardiovascular Devices
NONINVASIVE 870.5550 EXTERNAL TRANSCUTANEOUS CARDIAC PACEMAKER (NONINVASIVE) Cardiovascular Therapeutic Devices; Cardiovascular Devices
NONMEDICAL PURPOSES 510.112 ANTIBIOTICS USED IN VETERINARY MEDICINE AND FOR NONMEDICAL PURPOSES; REQUIRED DATA Specific Administrative Rulings And Decisions; New Animal Drugs
NONNARCOTIC 1308.21 APPLICATION FOR EXCLUSION OF A NONNARCOTIC SUBSTANCE Excluded Nonnarcotic Substances; Schedules Of Controlled Substances
NONNARCOTIC 1308.31 APPLICATION FOR EXEMPTION OF A NONNARCOTIC PRESCRIPTION PRODUCT Exempted Prescription Products; Schedules Of Controlled Substances
NONPARTIES 12.89 PARTICIPATION OF NONPARTIES Hearing Procedures; Formal Evidentiary Public Hearing
NONREBREATHING 868.5570 NONREBREATHING MASK Therapeutic Devices; Anesthesiology Devices
NONREBREATHING 868.5870 NONREBREATHING VALVE Therapeutic Devices; Anesthesiology Devices
NONRESORBABLE GAUZE 878.4014 NONRESORBABLE GAUZE SPONGE FOR EXTERNAL USE General And Plastic Surgery Devices
NONROLLER-TYPE 870.4360 NONROLLER-TYPE CARDIOPULMONARY BYPASS BLOOD PUMP Cardiovascular Surgical Devices; Cardiovascular Devices
NONSPECIFIC PROPERTIES 660.54 POTENCY TESTS, SPECIFICITY TESTS, TESTS FOR HETEROSPECIFIC ANTIBODIES, AND ADDITIONAL TESTS FOR NONSPECIFIC PROPERTIES
Procedures And Fees; Public Information
NONTRANSPARENT CONTAINERS 161.173 CANNED WET PACKED SHRIMP IN TRANSPARENT OR NONTRANSPARENT CONTAINERS Requirements For Specific Standardized Fish And Shellfish; Fish And Shellfish
NONTREPONEMAL REAGENTS 866.3820 TREPONEMA PALLIDUM NONTREPONEMAL TEST REAGENTS Serological Reagents; Immunology And Microbiology Devices
NONVENTILATORY 868.5640 MEDICINAL NONVENTILATORY NEBULIZER (ATOMIZER) Therapeutic Devices; Anesthesiology Devices
NONVOTING 14.84 NOMINATIONS AND SELECTION OF NONVOTING MEMBERS OF STANDING TECHNICAL ADVISORY COMMITTEES Members Of Advisory Committees; Public Hearing Before A Public Advisory Committee
NONVOTING 14.86 RIGHTS AND RESPONSIBILITIES OF NONVOTING MEMBERS OF ADVISORY COMMITTEES Members Of Advisory Committees; Public Hearing Before A Public Advisory Committee
NOODLE 139.150 NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NOODLE 139.155 ENRICHED NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NOODLE 139.160 VEGETABLE NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NOODLE 139.165 ENRICHED VEGETABLE NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NOODLE 139.180 WHEAT AND SOY NOODLE PRODUCTS Requirements For Specific Standardized Macaroni And Noodle Products; Macaroni And Noodle Products
NORDIHYDORGUAIARETIC ACID 189.165 NORDIHYDORGUAIARETIC ACID (NDGA) Substances Generally Prohibited From Direct Addition Or Use As Human Food; Substances Prohibited From Use In Human Food
NORGESTOMET 522.850 ESTRADIOL VALERATE AND NORGESTOMET IN COMBINATION Implantation Or Injectable Dosage Form New Animal Drugs
NORMAL PROPYL ALCOHOL 573.880 NORMAL PROPYL ALCOHOL Food Additive Listing; Food Additives Permitted In Feed And Drinking Water Of Animals
NOSE 874.3620 EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL Prosthetic Devices; Ear, Nose, And Throat Devices
NOSE 874.4140 EAR, NOSE, AND THROAT BURR Surgical Devices; Ear, Nose, And Throat Devices
NOSE 874.4250 EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL Surgical Devices; Ear, Nose, And Throat Devices
NOSE 874.4350 EAR, NOSE, AND THROAT FIBEROPTIC LIGHT SOURCE CARRIER Surgical Devices; Ear, Nose, And Throat Devices
NOSE 874.4420 EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT Surgical Devices; Ear, Nose, And Throat Devices
NOSE 874.4500 EAR, NOSE, AND THROAT MICROSURGICAL CARBON DIOXIDE LASER Surgical Devices; Ear, Nose, And Throat Devices
NOSE 874.5220 EAR, NOSE, AND THROAT DRUG ADMINISTRATION DEVICE Therapeutic Devices; Ear, Nose, And Throat Devices
NOSE 874.5300 EAR, NOSE AND THROAT EXAMINATION AND TREATMENT UNIT Therapeutic Devices; Ear, Nose, And Throat Devices
NOSE, ARTIFICIAL 868.5375 HEAT AND MOISTURE CONDENSER (ARTIFICIAL NOSE) Therapeutic Devices; Anesthesiology Devices
NOSE CLIP 868.6225 NOSE CLIP Miscellaneous; Anesthesiology Devices
NOSE PROSTHESIS 878.3680 NOSE PROSTHESIS Prosthetic Devices; General And Plastic Surgery Devices
NOT APPROVABLE 314.120 NOT APPROVABLE LETTER TO THE APPLICANT FDA Action On Applications; Applications For FDA Approval To Market A New Drug
NOTATION 21.53 NOTATION AND DISCLOSURE OF DISPUTED RECORDS Procedures For Requests For Amendment Of Records; Protection Of Privacy
NOTICE 1.90 NOTICE OF SAMPLING Imports And Exports; General Enforcement Regulation
NOTICE 5.100 ISSUANCE OF NOTICE IMPLEMENTING THE PROVISIONS OF THE DRUG AMENDMENTS OF 1962 Human Drugs; Redelegations Of Authority; Delegations Of Authority And
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
NOTICE 12.23 NOTICE OF FILING OF OBJECTIONS Initiation Of Proceedings; Formal Evidentiary Public Hearing
NOTICE 12.35 NOTICE OF HEARING; STAY OF ACTION Initiation Of Proceedings; Formal Evidentiary Public Hearing
NOTICE 12.45 NOTICE OF PARTICIPATION Appearance And Participation; Formal Evidentiary Public Hearing
NOTICE 12.95 OFFICIAL NOTICE Hearing Procedures; Formal Evidentiary Public Hearing
NOTICE 13.5 NOTICE OF A HEARING BEFORE A BOARD General Provisions; Public Hearing Before A Public Board Of Inquiry
NOTICE 14.20 NOTICE OF HEARING BEFORE AN ADVISORY COMMITTEE Meeting Procedures; Public Hearing Before A Public Advisory Committee
NOTICE 15.20 NOTICE OF A PUBLIC HEARING BEFORE THE COMMISSIONER Procedures For Public Hearing Before The Commissioner; Public Hearing Before The Commissioner
NOTICE 15.21 NOTICE OF PARTICIPATION; SCHEDULE FOR HEARING Procedures For Public Hearing Before The Commissioner; Public Hearing Before The Commissioner
NOTICE 17.13 NOTICE OF HEARING Civil Money Penalties Hearings
NOTICE 21.20 PROCEDURES FOR NOTICE OF FDA PRIVACY ACT RECORD SYSTEMS FDA Privacy Act Record Systems; Protection Of Privacy
NOTICE 21.74 PROVIDING NOTICE THAT A RECORD IS DISPUTED Disclosure Of Records In Privacy Act Record Systems To Persons Other ThanThe Subject Individual; Protection Of Privacy
NOTICE 58.204 NOTICE OF AND OPPORTUNITY FOR HEARING ON PROPOSED DISQUALIFICATION Disqualification Of Testing Facilities; Good Laboratory Practice For Nonclinical Laboratory Studies
NOTICE 60.42 NOTICE OF HEARING Due Diligence Petitions; Patent Term Restoration
NOTICE 71.2 NOTICE OF FILING OF PETITION General Provisions; Color Additive Petitions
NOTICE 101.17 FOOD LABELING WARNING, NOTICE, AND SAFE HANDLING STATEMENTS General Provisions; Food Labeling
NOTICE 133.10 NOTICE TO MANUFACTURERS, PACKERS, AND DISTRIBUTORS OF PASTEURIZED BLENDED CHEESE, PASTEURIZED PROCESS CHEESE, CHEESE FOOD, CHEESE SPREAD, AND RELATED FOODS General Provisions; Cheeses And Related Cheese Products
NOTICE 201.300 NOTICE TO MANUFACTURERS, PACKERS, AND DISTRIBUTORS OF GLANDULAR PREPARATIONS Specific Labeling Requirements For Specific Drug Products; Labeling
NOTICE 201.301 NOTICE TO MANUFACTURERS, PACKERS, AND DISTRIBUTORS OF ESTROGENIC HORMONE PREPARATIONS Specific Labeling Requirements For Specific Drug Products; Labeling
NOTICE 201.302 NOTICE TO MANUFACTURERS, PACKERS, AND DISTRIBUTORS OF DRUGS FOR INTERNAL USE WHICH CONTAIN MINERAL OIL Specific Labeling Requirements For Specific Drug Products; Labeling
NOTICE 314.52 NOTICE OF CERTIFICATION OF INVALIDITY OR NONINFRINGEMENT OF A PATENT Applications For FDA Approval To Market A New Drug
NOTICE 314.95 NOTICE OF CERTIFICATION OF INVALIDITY OR NONINFRINGEMENT OF A PATENT Applications For FDA Approval To Market A New Drug
NOTICE 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
NOTICE 314.200 NOTICE OF OPPORTUNITY FOR HEARING; NOTICE OF PARTICIPATION AND REQUEST FOR HEARING; GRANT OR DENIAL OF HEARING Hearing Procedures For New Drugs; Applications For FDA Approval To Market A New Drug
NOTICE 514.12 CONFIDENTIALITY OF DATA AND INFORMATION IN AN INVESTIGATIONAL NEW ANIMAL DRUG NOTICE General Provisions; New Animal Drug Applications
NOTICE 514.116 NOTICE OF WITHDRAWAL OF APPROVAL OF APPLICATION
Administrative Actions On Licenses; Medicated Feed Mill License
NOTICE 601.50 CONFIDENTIALITY OF DATA AND INFORMATION IN AN INVESTIGATIONAL NEW DRUG NOTICE FOR A BIOLOGICAL PRODUCT Confidentiality Of Information; Licensing
NOTICE 810.18 PUBLIC NOTICE Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTICE 1003.10 DISCOVERY OF DEFECT OR FAILURE OF COMPLIANCE BY MANUFACTURER; NOTICE REQUIREMENTS Discovery Of Defect Or Failure To Comply; Notification Of Defects Or Failure To Comply
NOTICE 1005.10 NOTICE OF SAMPLING Inspection And Testing; Importation Of Electronic Products
NOTICE 1316.06 NOTICE OF INSPECTION Administrative Inspections; Administrative Functions, Practices, And Procedures
NOTICE 1316.32 NOTICE OF PROCEEDING; TIME AND PLACE Enforcement Proceedings; Administrative Functions, Practices, And Procedures
NOTICE 1316.48 NOTICE OF APPEARANCE Administrative Hearings; Administrative Functions, Practices, And Procedures
NOTICE 1316.97 NOTICE PROVISIONS Expedited Forfeiture Proceedings For Certain Property; Administrative Functions, Practices, And Procedures
NOTICE 1404.312 NOTICE OF PROPOSED DEBARMENT Debarment; Governmentwide Debarment And Suspension And Requirements For Drug-Free Workplace (Grants)
NOTICE 1404.411 NOTICE OF SUSPENSION Suspension; Governmentwide Debarment And Suspension And Requirements For Drug-Free Workplace (Grants)
NOTICE, ADVANCE 1312.32 SCHEDULES II, III, IV: ADVANCE NOTICE Transshipment And In-Transit Shipment Of Controlled Substances; Importation And Exportation Of Controlled Substances
NOTICE, ADVANCE 1313.15 WAIVER OF 15-DAY ADVANCE NOTICE FOR REGULAR IMPORTERS Importation Of Listed Chemicals; Importation And Exportation Of Precursors And Essential Chemicals
NOTICE, ADVANCE 1313.24 WAIVER OF 15-DAY ADVANCE NOTICE FOR CHEMICAL EXPORTERS Exportation Of Listed Chemicals; Importation And Exportation Of Precursors And Essential Chemicals
NOTICE, ADVANCE 1313.31 ADVANCE NOTICE OF IMPORTATION FOR TRANSSHIPMENT OR TRANSFER Transshipment, In-Transit Shipments And International Transactions Involving Listed Chemicals; Importation And Exportation Of Precursors And Essential Chemicals
NOTICES 5.34 ISSUANCE OF NOTICES RELATING TO PROPOSALS AND ORDERS FOR DEBARMENT AND DENIAL OF AN APPLICATION TO TERMINATE DEBARMENT General Redelegations Of Authority; Delegations Of Authority And Organization
NOTICES 5.104 RESPONSES TO DRUG ENFORCEMENT ADMINISTRATION TEMPORARY SCHEDULING NOTICES Human Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
NOTICES 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
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
NOTICES 5.202 ISSUANCE OF NOTICES OF OPPORTUNITY FOR A HEARING ON PROPOSALS FOR DENIAL OF APPROVAL OF APPLICATIONS FOR LICENSES, SUSPENSION OR REVOCATION OF LICENSES AND CERTAIN NOTICES Biologics; Redelegations Of Authority; Delegations Of Authority And Organization
NOTICES 5.301 ISSUANCE OF INITIAL EMERGENCY PERMIT ORDERS AND NOTICES OF CONFIRMATION OF EFFECTIVE DATE OF FINAL REGULATIONS ON FOOD FOR HUMAN AND ANIMAL CONSUMPTION Foods And Cosmetics; Redelegations Of Authority; Delegations Of Authority And Organization
NOTICES 5.502 ISSUANCE OF NOTICES, PROPOSALS, AND ORDERS RELATING TO NEW ANIMAL DRUGS AND MEDICATED FEED MILL LICENSE APPLICATIONS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
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
NOTICES 10.80 DISSEMINATION OF DRAFT FEDERAL REGISTER NOTICES AND REGULATIONS General Administrative Procedures; Administrative Practices And Procedures
NOTICES 310.6 APPLICABILITY OF “NEW DRUG” OR SAFETY/EFFECTIVENESS FINDINGS IN DRUG EFFICACY STUDY IMPLEMENTATION NOTICES AND NOTICES OF OPPORTUNITY FOR HEARING TO IDENTICAL, RELATED, AND SIMILAR DRUG PRODUCTS General Provisions; New Drugs
NOTICES 514.121 SERVICE OF NOTICES AND ORDERS Administrative Actions On Applications; New Animal Drug Applications
NOTICES 515.26 SERVICE OF NOTICES AND ORDERS Administrative Actions On Licenses; Medicated Feed Mill License
NOTIFICATION 1.101 NOTIFICATION AND RECORDKEEPING Imports And Exports; General Enforcement Regulations
NOTIFICATION 5.204 NOTIFICATION OF RELEASE FOR DISTRIBUTION OF BIOLOGICAL PRODUCTS Biologics; Redelegations Of Authority; Delegations Of Authority And Organization
NOTIFICATION 5.401 ISSUANCE OF FEDERAL REGISTER DOCUMENTS PERTAINING TO EXEMPTIONS FROM PREMARKET NOTIFICATION Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
NOTIFICATION 5.404 NOTIFICATION TO PETITIONERS OF DETERMINATIONS MADE ON PETITIONS FOR RECLASSIFICATION OF MEDICAL DEVICES Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
NOTIFICATION 5.406 NOTIFICATION TO SPONSORS OF DEFICIENCIES IN PETITIONS FOR RECLASSIFICATION OF MEDICAL DEVICES Medical Devices And Radiological Health; Redelegations Of Authority; Delegations Of Authority And Organization
NOTIFICATION 5.603 NOTIFICATION OF DEFECTS IN, AND REPAIR OR REPLACEMENT OF, ELECTRONIC PRODUCTS Radiation Control; Redelegations Of Authority; Delegations Of Authority And Organization
NOTIFICATION 7.50 PUBLIC NOTIFICATION OF RECALL Recalls - Guidance On Policy, Procedures & Industry Responsibilities; Enforcement Policy
NOTIFICATION 21.40 PROCEDURES FOR SUBMITTING REQUESTS FOR NOTIFICATION AND ACCESS Procedures For Notification And Access To Records In Privacy Act Record Systems; Protection Of Privacy
NOTIFICATION 203.37 INVESTIGATION AND NOTIFICATION REQUIREMENTS Prescription Drug Marketing
NOTIFICATION 207.35 NOTIFICATION OF REGISTRANT; DRUG ESTABLISHMENT REGISTRATION NUMBER AND DRUG LISTING NUMBER Procedures For Domestic Drug Establishments; Registration Of Drug Producers And Listing Of Drugs In Commercial Distribution
NOTIFICATION 607.35 NOTIFICATION OF REGISTRANT; BLOOD PRODUCT ESTABLISHMENT REGISTRATION NUMBER AND NDC LABELER CODE Procedures For Domestic Blood Product Establishments; Establishment Registratn+product Listing, Manufacturers Human Blood/b.products
NOTIFICATION 710.6 NOTIFICATION OF REGISTRANT; COSMETIC PRODUCT ESTABLISHMENT REGISTRATION NUMBER Voluntary Registration Of Cosmetic Product Establishments
NOTIFICATION 720.7 NOTIFICATION OF PERSON SUBMITTING COSMETIC PRODUCT INGREDIENT STATEMENT Voluntary Filing Of Cosmetic Product Ingredient Composition Statements
NOTIFICATION 807.35 NOTIFICATION OF REGISTRANT Procedures For Device Establishments; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION 810.10 CEASE DISTRIBUTION AND NOTIFICATION ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTIFICATION 810.12 WRITTEN REQUEST FOR REVIEW OF CEASE DISTRIBUTION AND NOTIFICATION ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTIFICATION 810.14 CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL STRATEGY
NOTIFICATION OR MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTIFICATION 810.16 CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL STATUS REPORTS Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTIFICATION 810.17 TERMINATION OF A CEASE DISTRIBUTION AND NOTIFICATION OR MANDATORY RECALL ORDER Mandatory Medical Device Recall Procedures; Medical Device Recall Authority
NOTIFICATION 1002.3 NOTIFICATION TO USER OF PERFORMANCE AND TECHNICAL DATA General Provisions; Records And Reports
NOTIFICATION 1003.20 NOTIFICATION BY THE MANUFACTURER TO THE SECRETARY Notification; Notification Of Defects Or Failure To Comply
NOTIFICATION 1003.21 NOTIFICATION BY THE MANUFACTURER TO AFFECTED PERSONS Notification; Notification Of Defects Or Failure To Comply
NOTIFICATION, PREMARKET 190.6 REQUIREMENT FOR PREMARKET NOTIFICATION New Dietary Ingredient Notification; Dietary Supplements
NOTIFICATION, PREMARKET 807.81 WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION, PREMARKET 807.85 EXEMPTION FROM PREMARKET NOTIFICATION Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION, PREMARKET 807.87 INFORMATION REQUIRED IN A PREMARKET NOTIFICATION SUBMISSION Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION, PREMARKET 807.90 FORMAT OF A PREMARKET NOTIFICATION SUBMISSION Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION, PREMARKET 807.97 MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION, PREMARKET 807.100 FDA ACTION ON A PREMARKET NOTIFICATION Premarket Notification Procedures; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NOTIFICATION REQUIREMENTS 107.240 NOTIFICATION REQUIREMENTS Infant Formula Recalls; Infant Formula
NOTIFICATION REQUIREMENTS 610.47 “LOOK BACK” NOTIFICATION REQUIREMENTS FOR TRANSFUSION SERVICES Testing Requirements For Communicable Disease Agents; General Biological Products Standards
NOTIFICATION REQUIREMENTS 1003.30 APPLICATION FOR EXEMPTION FROM NOTIFICATION REQUIREMENTS Exemptions From Notification Requirements; Notification Of Defects Or Failure To Comply
NOVOBIOCIN 520.2345f TETRACYCLINE PHOSPHATE COMPLEX AND SODIUM NOVOBIOCIN CAPSULES Oral Dosage Form New Animal Drugs
NOVOBIOCIN 520.2345g TETRACYCLINE HYDROCHLORIDE AND SODIUM NOVOBIOCIN TABLETS Oral Dosage Form New Animal Drugs
NOVOBIOCIN 520.2345h TETRACYCLINE HYDROCHLORIDE, SODIUM NOVOBIOCIN, AND PREDNISOLONE TABLETS Oral Dosage Form New Animal Drugs
NOVOBIOCIN 526.1590 NOVOBIOCIN OIL SUSPENSION Intramammary Dosage Forms
NOVOBIOCIN 526.1696d PENICILLIN G PROCAINE-NOVOBIOCIN FOR INTRAMAMMARY INFUSION Intramammary Dosage Forms
NOVOBIOCIN 556.460 NOVOBIOCIN Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
NOVOBIOCIN 558.415 NOVOBIOCIN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
NUCLEAR CALIBRATION 892.1400 NUCLEAR SEALED CALIBRATION SOURCE Diagnostic Devices; Radiology Devices
NUCLEAR 892.1410 NUCLEAR ELECTROCARDIOGRAPH SYNCHRONIZER ELECTROCARDIOGRAPH Diagnostic Devices; Radiology Devices
NUCLEAR PHANTOM 892.1370 NUCLEAR ANTHROPOMORPHIC PHANTOM Diagnostic Devices; Radiology Devices
NUCLEAR PHANTOM 892.1380 NUCLEAR FLOOD SOURCE PHANTOM Diagnostic Devices; Radiology Devices
NUCLEAR SCANNER 892.1300 NUCLEAR RECTILINEAR SCANNER Diagnostic Devices; Radiology Devices
Diagnostic Devices; Radiology Devices
NUCLEAR TOMOGRAPHY 892.1310 NUCLEAR TOMOGRAPHY SYSTEM Diagnostic Devices; Radiology Devices
NUCLEAR UPTAKE PROBE 892.1320 NUCLEAR UPTAKE PROBE Diagnostic Devices; Radiology Devices
NUCLEAR WHOLE BODY 892.1130 NUCLEAR WHOLE BODY COUNTER COUNTER Diagnostic Devices; Radiology Devices
NUCLEOTIDASE 862.1520 5’-NUCLEOTIDASE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
NUMBER, CODE 1308.03 ADMINISTRATION CONTROLLED SUBSTANCES CODE NUMBER General Information; Schedules Of Controlled Substances
NUMBER, REGISTRATION 207.35 NOTIFICATION OF REGISTRANT; DRUG ESTABLISHMENT REGISTRATION NUMBER AND DRUG LISTING NUMBER Procedures For Domestic Drug Establishments; Registration Of Drug Producers And Listing Of Drugs In Commercial Distribution
NUMBER, REGISTRATION 207.39 MISBRANDING BY REFERENCE TO REGISTRATION OR TO REGISTRATION NUMBER Procedures For Domestic Drug Establishments; Registration Of Drug Producers And Listing Of Drugs In Commercial Distribution
NUMBER, REGISTRATION 607.35 NOTIFICATION OF REGISTRANT; BLOOD PRODUCT ESTABLISHMENT REGISTRATION NUMBER AND NDC LABELER CODE Procedures For Domestic Blood Product Establishments; Establishment Registratn+product Listing, Manufacturers Human Blood/b.products
NUMBER, REGISTRATION 607.39 MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER Procedures For Domestic Blood Product Establishments; Establishment Registratn+product Listing, Manufacturers Human Blood/b.products
NUMBER, REGISTRATION 710.6 NOTIFICATION OF REGISTRANT; COSMETIC PRODUCT ESTABLISHMENT REGISTRATION NUMBER Voluntary Registration Of Cosmetic Product Establishments
NUMBER, REGISTRATION 710.8 MISBRANDING BY REFERENCE TO REGISTRATION OR TO REGISTRATION NUMBER Voluntary Registration Of Cosmetic Product Establishments
NUMBER, REGISTRATION 807.39 MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER Procedures For Device Establishments; Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
NUMBER, REGISTRATION 1271.27 WILL FDA ASSIGN ME A REGISTRATION NUMBER? Procedures For Registration And Listing; Human Cells, Tissues, And Cellular And Tissue-Based Products
NUMBER OF SERVINGS 501.8 LABELING OF ANIMAL FOOD WITH NUMBER OF SERVINGS General Provisions; Animal Food Labeling
NUMBER, STATEMENT 720.9 MISBRANDING BY REFERENCE TO FILING OR TO STATEMENT NUMBER Voluntary Filing Of Cosmetic Product Ingredient Composition Statements
NUMBERS, CONTROL 201.18 DRUGS; SIGNIFICANCE OF CONTROL NUMBERS General Labeling Provisions; Labeling
NUMBERS, LOT/CONTROL 203.38 SAMPLE LOT OR CONTROL NUMBERS Labeling; Prescription Drug Marketing
NUMBERS, NDC 201.2 DRUGS AND DEVICES; NATIONAL DRUG CODE NUMBERS General Labeling Provisions; Labeling
NURSING 330.2 PREGNANCY-NURSING WARNING General Provisions; Over-the-counter Human Drugs Generally Recognized As Safe And Effective & Not Misbranded
NUTRIENT CONTENT 5.300 FOOD STANDARDS, FOOD ADDITIVES, GRAS SUBSTANCES, COLOR ADDITIVES, NUTRIENT CONTENT CLAIMS, AND HEALTH CLAIMS Foods And Cosmetics; Redelegations Of Authority; Delegations Of Authority And Organization
NUTRIENT CONTENT 101.13 NUTRIENT CONTENT CLAIMS - GENERAL PRINCIPLES General Provisions; Food Labeling
NUTRIENT CONTENT 101.54 NUTRIENT CONTENT CLAIMS FOR “GOOD SOURCE,” “HIGH,” “MORE,” AND “HIGH POTENCY” Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.56 NUTRIENT CONTENT CLAIMS FOR “LIGHT” OR “LITE” Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.60 NUTRIENT CONTENT CLAIMS FOR THE CALORIE CONTENT OF FOODS Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.61 NUTRIENT CONTENT CLAIMS FOR THE SODIUM CONTENT OF FOODS Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.62 NUTRIENT CONTENT CLAIMS FOR FAT, FATTY ACID, AND CHOLESTEROL
Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.67 USE OF NUTRIENT CONTENT CLAIMS FOR BUTTER Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 101.69 PETITIONS FOR NUTRIENT CONTENT CLAIMS Specific Requirements For Nutrient Content Claims; Food Labeling
NUTRIENT CONTENT 130.10 REQUIREMENTS FOR FOODS NAMED BY USE OF A NUTRIENT CONTENT CLAIM AND A STANDARDIZED TERM Food Standards: General
NUTRIENT INFORMATION 107.10 NUTRIENT INFORMATION Labeling; Infant Formula
NUTRIENT SPECIFICATIONS 107.100 NUTRIENT SPECIFICATIONS Nutrient Requirements; Infant Formula
NUTRITION LABELING 101.9 NUTRITION LABELING OF FOODS General Provisions; Food Labeling
NUTRITION LABELING 101.10 NUTRITION LABELING OF RESTAURANT FOODS General Provisions; Food Labeling
NUTRITION LABELING 101.36 NUTRITION LABELING OF DIETARY SUPPLEMENTS Food Labeling
NUTRITION LABELING 101.42 NUTRITION LABELING OF RAW FRUIT, VEGETABLES AND FISH Food Labeling
NUTRITION LABELING 101.45 NUTRITION LABELING OF RAW FRUIT, VEGETABLES, AND FISH Food Labeling
NUTRITION, PARENTERAL 201.323 ALUMINUM IN LARGE AND SMALL VOLUME PARENTERALS USED IN TOTAL PARENTERAL NUTRITION Specific Labeling Requirements For Specific Drug Products; Labeling
NUTRITIONAL LABELING 101.43 SUBSTANTIAL COMPLIANCE OF FOOD RETAILERS WITH THE GUIDELINES FOR THE VOLUNTARY NUTRITIONAL LABELING OF RAW FRUIT, VEGETABLES AND FISH Food Labeling
NUTS 164.110 MIXED NUTS Requirements For Specific Standardized Tree Nut And Peanut Products; Tree Nut And Peanut Products
NUTS 164.120 SHELLED NUTS IN RIGID OR SEMIRIGID CONTAINERS Requirements For Specific Standardized Tree Nut And Peanut Products; Tree Nut And Peanut Products
NUWORLD 133.164 NUWORLD CHEESE Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products
NYLON 175.360 VINYLIDENE CHLORIDE COPOLYMER COATINGS FOR NYLON FILM Substances For Use As Components Of Coatings; Indirect Food Additives
NYLON 177.1500 NYLON RESINS Substances For Use As Basic Components Of Single And Repeated Use Food Contact Surfaces; Indirect Food Additives: Polymers
NYLON 177.2355 MINERAL REINFORCED NYLON RESINS Substances For Use Only As Components Of Articles Intended For Repeated Use; Indirect Food Additives: Polymers
NYSTAGMOGRAPH 882.1460 NYSTAGMOGRAPH Neurological Diagnostic Devices; Neurological Devices
NYSTAGMUS 886.1905 NYSTAGMUS TAPE Diagnostic Devices; Ophthalmic Devices
NYSTATIN 524.1600 NYSTATIN OPHTHALMIC AND TOPICAL DOSAGE FORMS Ophthalmic And Topical Dosage Form New Animal Drugs
NYSTATIN 556.470 NYSTATIN Specific Tolerances For Residues Of New Animal Drugs; Tolerances For Residues Of New Animal Drugs In Food
NYSTATIN 558.430 NYSTATIN Specific New Animal Drugs For Use In Animal Feeds; New Animal Drugs For Use In Animal Feeds
