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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. |