Guidances directory

All guidance documents2,854 total

• CPG Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-VeterinariansCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43)Guidance Document · Center for Devices and Radiological Health
• Letter to Industry, Powered Wheelchair Manufacturers from RMJohnsonGuidance Document · Center for Devices and Radiological Health
• CPG Sec. 680.100 Tracers in Animal Feed (Withdrawn 10/19/2022)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston SyringesGuidance Document · Center for Devices and Radiological Health
• Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care FacilitiesGuidance Document · Center for Devices and Radiological Health
• Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and UrologyGuidance Document · Center for Devices and Radiological Health
• Guidance for the Content of Premarket Notifications for Ureteral StentsGuidance Document · Center for Devices and Radiological Health
• Volume Limits for Automated Collection of Source PlasmaMemorandum · Center for Biologics Evaluation and Research
• Preparation of Investigational New Drug Products (Human and Animal): Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 681.100 Order for Post-Approval Record Reviews (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 625.600 Orders for Post-Approval Record ReviewsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec 470100 Orders for Post-Approval Record ReviewsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Compliance Guide for Laser Products (FDA 86-8260)Guidance Document · Center for Devices and Radiological Health
• Statement of Policy - Foods Derived from New Plant VarietiesGuidance Document · Human Foods Program
• CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug ProductsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19Guidance Document · Center for Devices and Radiological Health
• Development of New Stereoisomeric DrugsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 420100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act *Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)*Compliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)Memorandum · Center for Biologics Evaluation and Research
• FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)Memorandum · Center for Biologics Evaluation and Research
• CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal GratuitiesCompliance Policy Guide (CPG) · Office of Regulatory Affairs Center for Drug Evaluation and Research,Office of Regulatory Policy
• CPG Sec 335800 Clinical Thermometer - Adulteration; Misbranding DefectsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Shelf Life of Medical DevicesGuidance Document · Center for Devices and Radiological Health
• Device Labeling Guidance #G91-1 (Blue Book Memo)Guidance Document · Center for Devices and Radiological Health
• Quality Assurance Guidelines for Hemodialysis DevicesGuidance Document · Center for Devices and Radiological Health
• 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