Guidances directory

All guidance documents2,828 total

• CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other ManipulationsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review programIndustry Letter · Center for Drug Evaluation and Research
• Format and Content of the Microbiology Section of an Application*: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42)Memorandum · Center for Devices and Radiological Health
• Review of FDA's Implementation of the Drug Export Amendments of 1986Guidance Document · Center for Drug Evaluation and Research
• Study of Drugs Likely to be used in the ElderlyGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 540.550 Kipper and Kipper Unsplit - DefinitionsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 540.450 *Imitation Breaded Shrimp*Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 540.390 Canned Shrimp - Labeling, Size Designations and Corresponding CountsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 540.150 Caviar, Use of Term - LabelingCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 560.250 Imports - Importer can be Required to Reveal Identity of IngredientsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)Guidance Document · Center for Devices and Radiological Health
• CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate IngredientsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal ViolationCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 160.300 Requests for Records Under Section 703Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 140.100 Seizure of Books that Constitute Misleading LabelingCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 130.200 Inspection of Firms when Legal Action is PendingGuidance Document · Office of Regulatory Affairs
• CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United StatesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded CarriersCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade ZonesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 100.800 Guaranties Over Printed SignaturesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper ProductsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations Center for Devices and Radiological Health Center for Drug Evaluation and Research
• CPG Sec. 100.500 - Common Carrier as a Relabeler, Repacker, Reprocessor, etc.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 400.700 Drug Product Entries in Periodic PublicationsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 160.700 Reconditioning of Foods Adulterated Under 402(a)(4)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 560.350 Coffee and Cocoa Bean SweepsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 560.300 Reconditioning of Imported, Insect Infested, Insect Damaged or Moldy Coffee BeansCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 560.100 Importation of Unlabeled Foods - Exemption Under *21 CFR 101.100(d)*Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In VitroGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 690.500 Uncooked Meat for Animal Food (Withdrawn 4/30/2019)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 )Guidance Document · Center for Devices and Radiological Health
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3)Guidance Document · Center for Devices and Radiological Health
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2)Memorandum · Center for Devices and Radiological Health
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)Guidance Document · Center for Devices and Radiological Health
• CPG Sec 562.800 Vending Machine Food - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 562.750 Labeling of Food Articles Distributed Solely in Puerto RicoCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 562.700 Labeling of Food Bearing Residues of Pesticide ChemicalsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 562.600 Preservatives; Use in Nonstandardized Foods; Label DeclarationCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 562.100 Acetic Acid - Use in Foods - Labeling of Foods in Which UsedCompliance Policy Guide (CPG) · Human Foods Program
• Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 8685905 Non-continuous Ventilator Class IIGuidance Document · Center for Devices and Radiological Health
• CPG Sec 555850 Water Damaged Food Products in Screw-Top, Crimped-Cap and Similar ContainersCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555550 Foods, Standardized; Enriched or Fortified - Adulteration Involving Misbranding - PotencyCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 562.650 "Processing" - Use of Term in Section 405 of the FD&C ActCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 555.875 Water in Food Products (Ingredient or Adulterant)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 555.800 Polysorbates 20, 40, 60, 65, 80, 85 - Common or Usual NamesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 555.750 Seeds for Sprouting Prior to Food Use, i.e., Dried Mung Beans, Alfalfa Seeds, Etc.Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 555.100 Alcohol; Use of Synthetic Alcohol in FoodsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 570.550 Reconditioning - Tree Nuts Contaminated with E. coliCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.100 Artichoke; Jerusalem Artichoke - Common or Usual NameCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.850 Sweet Potatoes - Sirup PackCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 585.800 Squash Seeds - Labeling as Pumpkin SeedsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.725 "Pumpkin" - Labeling Articles Made from Certain Varieties of SquashCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.710 Potato Chips, Ingredients - LabelingCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.650 Canned Pimentos and Red Sweet Peppers - Seeds Should be RemovedCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.625 Canned Peas - Label Designation of SizesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.600 Peas and Carrots, Labeling of Canned MixtureCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585.525: Mushroom Mycelium - Fitness for Food; LabelingCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 585350 Corn Husks (for Tamales) - Adulteration with FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585700 Potato Chips - Adulteration with RotCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585450 Greens, Canned - Adulteration by MildewCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585260 Broccoli, Frozen - Adulteration with InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585150 Asparagus, Canned or Frozen - Adulteration with Insect FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 570.250 Cashews, Insect Infested - ReconditioningCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 570.100 Jordan Almonds - Common or Usual NameCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and TabletsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec 510.100 Beverage BasesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&CIndustry Letter · Center for Drug Evaluation and Research
• Format and Content of the Clinical and Statistical Sections of an ApplicationGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 545.200 Confectionery Decorations (Nutritive and Non-Nutritive)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 578300 Wheat - Adulteration by Insect and Rodent filthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 578200 Corn Meal - Adulteration by Insect and Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 515.800 Labeling of Products Purporting to be "Chocolate" or "Chocolate Flavored"Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance ActivityCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample AnalysisCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 505.350 Honey Bread, Honey BunsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 505.300 "Butter-Nut" BreadCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 505.200 "Butter" Featured in Product NameCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)Guidance Document · Center for Devices and Radiological Health
• Quality Control Guide for Sunlamp Products (FDA 88-8234)Guidance Document · Center for Devices and Radiological Health
• CPG Sec 578450 Wheat Flour-Adulteration with Insect Fragments and Rodent HairsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)Memorandum · Center for Biologics Evaluation and Research
• CPG Sec 565.200 Red Meat Adulterated with PCBsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40)Guidance Document · Center for Devices and Radiological Health
• CPG Sec. 160.600 Payment of Expert WitnessesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 460.600 Content Uniformity Testing of Tablets and CapsulesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 567.200 Pork and Beans and Similar Bean Products - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 345.200 Diaphragms - Rx DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by OstomatesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 320.100 Ear Piercing DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 300.100 Inspection of Manufacturers of Device ComponentsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control RecordsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 425.400 Computerized Drug Processing; Input/Output CheckingCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 425.200 Computerized Drug Processing; Vendor ResponsibilityCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software*Compliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations*Compliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 567.300 *Bouillon, Bouillon Cubes, Granulated Bouillon*Compliance Policy Guide (CPG) · Human Foods Program
• CPG Sec 567.100 Antipasto, Common or Usual NameCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 100.300 *Non-FDA Regulated Products Involving Communicable Disease Hazards*Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 100.100 Responsibility for Reporting Possible or Potential Violations of Laws Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public HealthCompliance Policy Guide (CPG) · Office of Regulatory Affairs