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 21 CFR

Part 5: Delegations of authority and organization
  §5.25 - Research, investigation, and testing programs and health information and promotion programs.
  §5.30 - Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.

Part 7: Enforcement policy
  §7.12 - Guaranty.
  §7.13 - Suggested forms of guaranty.
  §7.84 - Opportunity for presentation of views before report of criminal violation.

Part 10: Administrative practices and procedures
  §10.20 - Submission of documents to Dockets Management Branch; computation of time; availability for public disclosure.
  §10.70 - Documentation of significant decisions in administrative file.
  §10.95 - Participation in outside standard-setting activities.

Part 11: Electronic records; electronic signatures
  §11.3 - Definitions.
  §11.10 - Controls for closed systems.
  §11.50 - Signature manifestations.
  §11.100 - General requirements.
  §11.200 - Electronic signature components and controls.

Part 12: Formal evidentiary public hearing
  §12.45 - Notice of participation.
  §12.85 - Disclosure of data and information by the participants.
  §12.92 - Prehearing conference procedure.

Part 13: Public hearing before a public board of inquiry
  §13.25 - Disclosure of data and information by the participants.

Part 17: Civil money penalties hearings
  §17.5 - Complaint.
  §17.31 - Form, filing, and service of papers.

Part 20: Public information
  §20.44 - Presubmission review of request for confidentiality of voluntarily submitted data or information.
  §20.47 - Denial of a request for records.
  §20.88 - Communications with State and local government officials.
  §20.89 - Communications with foreign government officials.
  §20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and organizations.

Part 25: Environmental impact considerations
  §25.41 - Findings of no significant impact.

Part 26: Mutual recognition of pharmaceutical good manufacturing practice reports, medical device quality system audit reports, and certain medical device product evaluation reports: United States and The European Community
  §26.0 - General.
  §26.11 - Start of operational period.

Part 50: Protection of human subjects
  §50.27 - Documentation of informed consent.

Part 54: Financial disclosure by clinical investigators
  §54.4 - Certification and disclosure requirements.

Part 56: Institutional Review Boards
  §56.109 - IRB review of research.

Part 58: Good laboratory practice for nonclinical laboratory studies
  §58.35 - Quality assurance unit.
  §58.90 - Animal care.
  §58.120 - Protocol.
  §58.130 - Conduct of a nonclinical laboratory study.
  §58.185 - Reporting of nonclinical laboratory study results.

Part 71: Color additive petitions
  §71.1 - Petitions.
  §71.2 - Notice of filing of petition.

Part 80: Color additive certification
  §80.21 - Request for certification.

Part 99: Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices
  §99.201 - Manufacturer's submission to the agency.

Part 100: General
  §100.2 - State enforcement of Federal regulations.

Part 101: Food labeling
  §101.9 - Nutrition labeling of food.
  §101.22 - Foods; labeling of spices, flavorings, colorings and chemical preservatives.
  §101.45 - Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.
  §101.69 - Petitions for nutrient content claims.
  §101.93 - Certain types of statements for dietary supplements.
  §101.100 - Food; exemptions from labeling.

Part 110: Current good manufacturing practice in manufacturing, packing, or holding human food
  §110.37 - Sanitary facilities and controls.

Part 113: Thermally processed low-acid foods packaged in hermetically sealed containers
  §113.100 - Processing and production records.

Part 120: Hazard Analysis and Critical Control Point (HACCP) systems
  §120.11 - Verification and validation.
  §120.12 - Records.
  §120.14 - Application of requirements to imported products.

Part 123: Fish and fishery products
  §123.6 - Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  §123.8 - Verification.
  §123.12 - Special requirements for imported products.

Part 170: Food additives
  §170.35 - Affirmation of generally recognized as safe (GRAS) status.

Part 171: Food additive petitions
  §171.1 - Petitions.

Part 179: Irradiation in the production, processing and handling of food
  §179.26 - Ionizing radiation for the treatment of food.

Part 201: Labeling
  §201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.
  §201.150 - Drugs; processing, labeling, or repacking.

Part 203: Prescription drug marketing
  §203.3 - Definitions.
  §203.31 - Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).
  §203.60 - Request and receipt forms, reports, and records.

Part 207: Registration of producers of drugs and listing of drugs in commercial distribution
  §207.20 - Who must register and submit a drug list.
  §207.26 - Amendments to registration.

Part 208: Medication Guides for prescription drug products
  §208.20 - Content and format of a Medication Guide.

Part 211: Current good manufacturing practice for finished pharmaceuticals
  §211.182 - Equipment cleaning and use log.
  §211.186 - Master production and control records.
  §211.188 - Batch production and control records.

Part 225: Current good manufacturing practice for medicated feeds
  §225.102 - Master record file and production records.

Part 250: Special requirements for specific human drugs
  §250.250 - Hexachlorophene, as a component of drug and cosmetic products.

Part 310: New drugs
  §310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.

Part 312: Investigational new drug application
  §312.23 - IND content and format.
  §312.53 - Selecting investigators and monitors.
  §312.56 - Review of ongoing investigations.
  §312.60 - General responsibilities of investigators.
  §312.62 - Investigator recordkeeping and record retention.

Part 314: Applications for FDA approval to market a new drug
  §314.50 - Content and format of an application.
  §314.53 - Submission of patent information.
  §314.72 - Change in ownership of an application.
  §314.94 - Content and format of an abbreviated application.

Part 315: Diagnostic radiopharmaceuticals
  §315.6 - Evaluation of safety.

Part 316: Orphan drugs
  §316.10 - Content and format of a request for written recommendations.
  §316.20 - Content and format of a request for orphan-drug designation.

Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use
  §341.74 - Labeling of antitussive drug products.
  §341.78 - Labeling of expectorant drug products.

Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use
  §343.80 - Professional labeling.

Part 358: Miscellaneous external drug products for over-the-counter human use
  §358.150 - Labeling of wart remover drug products.
  §358.550 - Labeling of corn and callus remover drug products.

Part 361: Prescription drugs for human use generally recognized as safe and effective and not misbranded: Drugs used in research
  §361.1 - Radioactive drugs for certain research uses.

Part 501: Animal food labeling
  §501.22 - Animal foods; labeling of spices, flavorings, colorings, and chemical preservatives.
  §501.100 - Animal food; exemptions from labeling.

Part 511: New animal drugs for investigational use
  §511.1 - New animal drugs for investigational use exempt from section 512(a) of the act.

Part 514: New animal drug applications
  §514.1 -   
  §514.80 - Records and reports concerning experience with approved new animal drugs.
  §514.117 - Adequate and well-controlled studies.

Part 515: Medicated feed mill license
  §515.10 - Medicated feed mill license applications.
  §515.11 - Supplemental medicated feed mill license applications.
  §515.20 - Approval of medicated feed mill license applications.

Part 520: Oral dosage form new animal drugs
  §520.88g - Amoxicillin trihydrate and clavulanate potassium film-coated tablets.
  §520.90d - Ampicillin trihydrate for oral suspension.
  §520.154a - Soluble bacitracin methylene disalicylate.
  §520.260 - n-Butyl chloride capsules.
  §520.420 - Chlorothiazide tablets and boluses.
  §520.434 - Chlorphenesin carbamate tablets.
  §520.452 - Clenbuterol syrup.
  §520.540b - Dexamethasone tablets and boluses.
  §520.540c - Dexamethasone chewable tablets.
  §520.550 - Dextrose/glycine/electrolyte.
  §520.600 - Dichlorvos.
  §520.645 - Difloxacin.
  §520.784 - Doxylamine succinate tablets.
  §520.960 - Flumethasone tablets.
  §520.1157 - Iodinated casein tablets.
  §520.1263c - Lincomycin hydrochloride soluble powder.
  §520.1331 - Meclofenamic acid tablets.
  §520.1408 - Methylprednisolone tablets.
  §520.1409 - Methylprednisolone, aspirin tablets.
  §520.1616 - Orbifloxacin tablets.
  §520.1696b - Penicillin G potassium in drinking water.
  §520.1880 - Prednisolone tablets.
  §520.2098 - Selegiline hydrochloride tablets.
  §520.2170 - Sulfabromomethazine sodium boluses.
  §520.2260b - Sulfamethazine sustained-release boluses.
  §520.2280 - Sulfamethizole and methenamine mandelate tablets.
  §520.2345h - Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets.
  §520.2611 - Trimethoprim and sulfadiazine oral paste.
  §520.2613 - Trimethoprim and sulfadiazine powder.

Part 522: Implantation or injectable dosage form new animal drugs
  §522.90a - Ampicillin trihydrate sterile suspension.
  §522.163 - Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.
  §522.311 - Carfentanil citrate injection.
  §522.313 - Ceftiofur sodium powder for injection.
  §522.540 - Dexamethasone injection.
  §522.784 - Doxylamine succinate injection.
  §522.812 - Enrofloxacin solution.
  §522.1020 - Gelatin solution.
  §522.1125 - Hemoglobin glutamer-200 (bovine).
  §522.1150 - Hydrochlorothiazide injection.
  §522.1156 - Imidocarb dipropionate solution.
  §522.1182 - Iron dextran complex injection.
  §522.1850 - Polysulfated glycosaminoglycan.
  §522.1883 - Prednisolone sodium phosphate injection, sterile.
  §522.1890 - Sterile prednisone suspension.
  §522.2063 - Pyrilamine maleate injection.
  §522.2610 - Trimethoprim and sulfadiazine sterile suspension.
  §522.2615 - Tripelennamine hydrochloride injection.

Part 524: Ophthalmic and topical dosage form new animal drugs
  §524.1044d - Gentamicin sulfate, betamethasone valerate ointment.
  §524.1044e - Gentamicin sulfate spray.
  §524.1484c - Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride ointment.
  §524.1484d - Neomycin sulfate, hydrocortisone acetate, tetracaine hydrochloride ear ointment.
  §524.1484f - Neomycin sulfate, prednisolone acetate, tetracaine hydrochloride eardrops.
  §524.1484k - Neomycin sulfate, prednisolone, tetracaine, and squalane topical-otic suspension.

Part 529: Certain other dosage form new animal drugs
  §529.1030 - Formalin solution.

Part 558: New animal drugs for use in animal feeds
  §558.6 - Veterinary feed directive drugs.
  §558.325 - Lincomycin.
  §558.364 - Neomycin sulfate.
  §558.485 - Pyrantel tartrate.
  §558.515 - Robenidine hydrochloride.
  §558.575 - Sulfadimethoxine, ormetoprim.
  §558.586 - Sulfaquinoxoline.
  §558.600 - Tiamulin.

Part 570: Food additives
  §570.35 - Affirmation of generally recognized as safe (GRAS) status.

Part 571: Food additive petitions
  §571.1 - Petitions.

Part 601: Licensing
  §601.2 - Applications for biologics licenses; procedures for filing.
  §601.25 - Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
  §601.35 - Evaluation of safety.

Part 606: Current good manufacturing practice for blood and blood components
  §606.151 - Compatibility testing.
  §606.160 - Records.

Part 640: Additional standards for human blood and blood products
  §640.65 - Plasmapheresis.
  §640.101 - General requirements.

Part 701: Cosmetic labeling
  §701.9 - Exemptions from labeling requirements.

Part 720: Voluntary filing of cosmetic product ingredient composition statements
  §720.4 - Information requested about cosmetic products.
  §720.7 - Notification of person submitting cosmetic product ingredient statement.

Part 800: General
  §800.55 - Administrative detention.

Part 801: Labeling
  §801.150 - Medical devices; processing, labeling, or repacking.
  §801.421 - Hearing aid devices; conditions for sale.
  §801.430 - User labeling for menstrual tampons.

Part 807: Establishment registration and device listing for manufacturers and initial importers of devices
  §807.93 - Content and format of a 510(k) statement.
  §807.94 - Format of a class III certification.

Part 808: Exemptions from Federal preemption of State and local medical device requirements
  §808.20 - Application.

Part 812: Investigational device exemptions
  §812.20 - Application.
  §812.36 - Treatment use of an investigational device.
  §812.43 - Selecting investigators and monitors.
  §812.46 - Monitoring investigations.
  §812.100 - General responsibilities of investigators.
  §812.110 - Specific responsibilities of investigators.
  §812.140 - Records.

Part 814: Premarket approval of medical devices
  §814.20 - Application.
  §814.44 - Procedures for review of a PMA.
  §814.102 - Designation of HUD status.
  §814.104 - Original applications.
  §814.124 - Institutional Review Board requirements.

Part 868: Anesthesiology devices
  §868.1920 - Esophageal stethoscope with electrical conductors.
  §868.2875 - Differential pressure transducer.
  §868.2885 - Gas flow transducer.
  §868.2900 - Gas pressure transducer.

Part 870: Cardiovascular devices
  §870.1025 - Arrhythmia detector and alarm.
  §870.1100 - Blood pressure alarm.
  §870.1110 - Blood pressure computer.
  §870.1130 - Noninvasive blood pressure measurement system.
  §870.1270 - Intracavitary phonocatheter system.
  §870.1670 - Syringe actuator for an injector.
  §870.2050 - Biopotential amplifier and signal conditioner.
  §870.2060 - Transducer signal amplifier and conditioner.
  §870.2100 - Cardiovascular blood flowmeter.
  §870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).
  §870.2310 - Apex cardiograph (vibrocardiograph).
  §870.2340 - Electrocardiograph.
  §870.2360 - Electrocardiograph electrode.
  §870.2390 - Phonocardiograph.
  §870.2400 - Vectorcardiograph.
  §870.2450 - Medical cathode-ray tube display.
  §870.2600 - Signal isolation system.
  §870.2800 - Medical magnetic tape recorder.
  §870.2810 - Paper chart recorder.
  §870.2850 - Extravascular blood pressure transducer.
  §870.2890 - Vessel occlusion transducer.
  §870.2900 - Patient transducer and electrode cable (including connector).
  §870.2910 - Radiofrequency physiological signal transmitter and receiver.
  §870.2920 - Telephone electrocardiograph transmitter and receiver.
  §870.3680 - Cardiovascular permanent or temporary pacemaker electrode.

Part 874: Ear, nose, and throat devices
  §874.1050 - Audiometer.
  §874.1120 - Electronic noise generator for audiometric testing.
  §874.4750 - Laryngostroboscope.

Part 876: Gastroenterology-urology devices
  §876.1620 - Urodynamics measurement system.
  §876.1725 - Gastrointestinal motility monitoring system.
  §876.1735 - Electrogastrography system.
  §876.1800 - Urine flow or volume measuring system.

Part 880: General hospital and personal use devices
  §880.2400 - Bed-patient monitor.
  §880.2420 - Electronic monitor for gravity flow infusion systems.
  §880.2460 - Electrically powered spinal fluid pressure monitor.
  §880.2720 - Patient scale.
  §880.2910 - Clinical electronic thermometer.

Part 882: Neurological devices
  §882.1320 - Cutaneous electrode.
  §882.1330 - Depth electrode.
  §882.1350 - Needle electrode.
  §882.1420 - Electroencephalogram (EEG) signal spectrum analyzer.
  §882.1430 - Electroencephalograph test signal generator.
  §882.1835 - Physiological signal amplifier.
  §882.1845 - Physiological signal conditioner.
  §882.1855 - Electroencephalogram (EEG) telemetry system.
  §882.5050 - Biofeedback device.

Part 884: Obstetrical and gynecological devices
  §884.2050 - Obstetric data analyzer.
  §884.2225 - Obstetric-gynecologic ultrasonic imager.
  §884.2600 - Fetal cardiac monitor.
  §884.2640 - Fetal phonocardiographic monitor and accessories.
  §884.2660 - Fetal ultrasonic monitor and accessories.
  §884.2700 - Intrauterine pressure monitor and accessories.
  §884.2740 - Perinatal monitoring system and accessories.
  §884.2960 - Obstetric ultrasonic transducer and accessories.
  §884.2980 - Telethermographic system.

Part 886: Ophthalmic devices
  §886.1640 - Ophthalmic preamplifier.
  §886.5900 - Electronic vision aid.

Part 890: Physical medicine devices
  §890.1375 - Diagnostic electromyograph.
  §890.1385 - Diagnostic electromyograph needle electrode.
  §890.1575 - Force-measuring platform.
  §890.1615 - Miniature pressure transducer.

Part 892: Radiology devices
  §892.1100 - Scintillation (gamma) camera.
  §892.1110 - Positron camera.
  §892.1130 - Nuclear whole body counter.
  §892.1170 - Bone densitometer.
  §892.1200 - Emission computed tomography system.
  §892.1220 - Fluorescent scanner.
  §892.1300 - Nuclear rectilinear scanner.
  §892.1310 - Nuclear tomography system.
  §892.1320 - Nuclear uptake probe.
  §892.1330 - Nuclear whole body scanner.
  §892.1390 - Radionuclide rebreathing system.
  §892.1540 - Nonfetal ultrasonic monitor.
  §892.1550 - Ultrasonic pulsed doppler imaging system.
  §892.1560 - Ultrasonic pulsed echo imaging system.
  §892.1570 - Diagnostic ultrasonic transducer.
  §892.1600 - Angiographic x-ray system.
  §892.1630 - Electrostatic x-ray imaging system.
  §892.1650 - Image-intensified fluoroscopic x-ray system.
  §892.1660 - Non-image-intensified fluoroscopic x-ray system.
  §892.1680 - Stationary x-ray system.
  §892.1710 - Mammographic x-ray system.
  §892.1720 - Mobile x-ray system.
  §892.1730 - Photofluorographic x-ray system.
  §892.1740 - Tomographic x-ray system.
  §892.1750 - Computed tomography x-ray system.
  §892.1970 - Radiographic ECG/respirator synchronizer.
  §892.5050 - Medical charged-particle radiation therapy system.
  §892.5300 - Medical neutron radiation therapy system.
  §892.5750 - Radionuclide radiation therapy system.
  §892.5840 - Radiation therapy simulation system.
  §892.5900 - X-ray radiation therapy system.

Part 898: Performance standard for electrode lead wires and patient cables
  §898.13 - Compliance dates.

Part 900: Mammography
  §900.2 - Definitions.

Part 1000: General
  §1000.15 - Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

Part 1002: Records and reports
  §1002.7 - Submission of data and reports.
  §1002.10 - Product reports.

Part 1005: Importation of electronic products
  §1005.25 - Service of process on manufacturers.

Part 1020: Performance standards for ionizing radiation emitting products
  §1020.20 - Cold-cathode gas discharge tubes.
  §1020.30 - Diagnostic x-ray systems and their major components.
  §1020.31 - Radiographic equipment.
  §1020.32 - Fluoroscopic equipment.
  §1020.40 - Cabinet x-ray systems.

Part 1030: Performance standards for microwave and radio frequency emitting products
  §1030.10 - Microwave ovens.

Part 1210: Regulations under the Federal Import Milk Act
  §1210.23 - Permits granted on certificates.

Part 1230: Regulations under the Federal Caustic Poison Act
  §1230.47 - Rejected containers.
  §1230.48 - Relabeling of containers.

Part 1250: Interstate conveyance sanitation
  §1250.38 - Toilet and lavatory facilities for use of food-handling employees.
  §1250.67 - Watering equipment.

Part 1270: Human tissue intended for transplantation
  §1270.3 - Definitions.

Part 1301: Registration of manufacturers, distributors, and dispensers of controlled substances
  §1301.17 - Special procedures for certain applications.
  §1301.51 - Modification in registration.
  §1301.72 - Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; storage areas.
  §1301.73 - Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
  §1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.

Part 1303: Quotas
  §1303.12 - Procurement quotas.

Part 1304: Records and reports of registrants
  §1304.31 - Reports from manufacturers importing narcotic raw material.

Part 1305: Order forms
  §1305.05 - Procedure for obtaining order forms.
  §1305.06 - Procedure for executing order forms.
  §1305.07 - Power of attorney.
  §1305.10 - Procedure for endorsing order forms.

Part 1306: Prescriptions
  §1306.05 - Manner of issuance of prescriptions.
  §1306.11 - Requirement of prescription.
  §1306.21 - Requirement of prescription.
  §1306.22 - Refilling of prescriptions.

Part 1309: Registration of manufacturers, distributors, importers and exporters of list I chemicals
  §1309.32 - Application forms; contents; signature.
  §1309.61 - Modification in registration.

Part 1310: Records and reports of listed chemicals and certain machines
  §1310.05 - Reports.

Part 1312: Importation and exportation of controlled substances
  §1312.13 - Issuance of import permit.
  §1312.19 - Distribution of import declaration.
  §1312.22 - Application for export permit.
  §1312.28 - Distribution of special controlled substances invoice.
  §1312.31 - Schedule I: Application for prior written approval.

Part 1316: Administrative functions, practices, and procedures
  §1316.08 - Consent to inspection.
  §1316.52 - Presiding officer.
  §1316.91 - Definitions.

Part 1404: Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants)
  §1404.635 - Reporting of and employee sanctions for convictions of criminal drug offenses.

 

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