Guidances directory

All guidance documents2,828 total

• CPG Sec. 687.500 Silage IngredientsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 685.100 Recycled Animal WasteCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 480.100 Requirements for Expiration Dating and Stability TestingCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds (Withdrawn 1/30/2023)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover (Withdrawn 1/30/2023)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 675.300 Moisture Damaged GrainCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 675.200 Diversion of Adulterated Food to Acceptable Animal Feed UseCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 675.100 Diversion of Contaminated Food for Animal UseCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 670.500 Ammoniated Cottonseed Meal - Interpretation of 21 CFRCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 665.100 Common or Usual Names for Animal Feed Ingredients (Withdrawn 1/6/2025)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec 562.400 Foreign Language Declarations on Food LabelsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 654.200 Teat Dips and Udder Washes for Dairy Cows and GoatsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 643.100 Oral Iron Products for Baby Pigs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 642.100 *Drugs for Odor Control and Conception in Pet Animals*Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 640.100 Anthelmintics (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
• CPG Sec. 150.500 Analytical Methodology Used by FDA - DrugsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations Center for Drug Evaluation and Research
• CPG Sec. 638.100 Process Validation Requirements for Drug Products Subject to Pre-Market ApprovalCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product LabelsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec.625.400 Reconditioning of New Animal Drugs Seized Under Section 501(a)(5) (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec 555.650 Reconditioning Foods by Diversion for Animal FeedCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e)Guidance Document · Office of Regulatory Affairs
• CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary DevicesCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray EquipmentGuidance Document · Office of Regulatory Affairs
• CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device ManufacturersCompliance Policy Guide (CPG) · Office of Regulatory Affairs Center for Devices and Radiological Health
• CPG Sec. 398.200 Hazardous Diagnostic X-ray SystemsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 396.400 Policy on Warned on Sunlamp ProductsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 396.200 Exemption for Certain Sunlamp Product Purchaser RecordsGuidance Document · Office of Regulatory Affairs
• CPG Sec 525.400 Hollandaise Sauce - Common or Usual NameCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning ProductsGuidance Document · Office of Regulatory Affairs
• CPG Sec. 394.100 Retention of Microwave Oven Test RecordsGuidance Document · Office of Regulatory Affairs
• CPG Sec 520.100 Canned Foods, Use of the Term "Solid Pack"Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 550.400 GrenadineCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 515.425 Sugar - Water Damaged - ReconditioningCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 310.100 Pacemaker ReuseCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling RequirementsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec 275.100 Immune Milk (Withdrawn 1/30/2020) : CPG Sec 275.100 Immune MilkCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 253.100- Use of Units of *Plasma and Fresh Frozen Plasma* Which Have Been ThawedGuidance Document · Office of Regulatory Affairs
• CPG Sec. 252.100 Source Plasma - Regulatory Action Based on Overbleeding (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 250.100 Source Plasma – Guidelines for Informed Consent Forms (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 231.110- Quality Control Testing of *Platelets* [ ] and Cryoprecipitated Antihemophilic Factor [ ]Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip SystemsGuidance Document · Center for Devices and Radiological Health
• CVM GFI #57 Preparation and Submission of Veterinary Master FilesGuidance Document · Center for Veterinary Medicine
• Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and UrologyGuidance Document · Center for Devices and Radiological Health
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsGuidance Document · Center for Devices and Radiological Health
• Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersGuidance Document · Center for Devices and Radiological Health
• Format and Content for the CMC Section of an Annual ReportGuidance Document · Center for Drug Evaluation and Research
• Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)Guidance Document · Center for Devices and Radiological Health
• CPG Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
• E7 Studies in Support of Special Populations: GeriatricsGuidance Document · Center for Drug Evaluation and Research
• Points to Consider for Cervical Cytology DevicesGuidance Document · Center for Devices and Radiological Health
• Guidance for the Content of Premarket Notifications for Urine Drainage BagsGuidance Document · Center for Devices and Radiological Health
• CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol DevelopmentGuidance Document · Center for Veterinary Medicine
• CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic AnimalsGuidance Document · Center for Veterinary Medicine
• Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone CementGuidance Document · Center for Devices and Radiological Health
• Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom ProductsGuidance Document · Center for Devices and Radiological Health
• Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 102031(g) :Guidance Document · Center for Devices and Radiological Health
• Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps ContainersGuidance Document · Center for Devices and Radiological Health
• Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and ActuatorsGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Guidelines for Determining Metric Equivalents of Household MeasuresGuidance Document · Human Foods Program
• 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
• 1993 Draft Redbook IIGuidance Document · Human Foods Program
• Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesGuidance Document · Center for Devices and Radiological Health
• Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical DrapesGuidance Document · Center for Devices and Radiological Health
• CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef CattleGuidance Document · Center for Veterinary Medicine
• Study and Evaluation of Sex Differences in the Clinical Evaluation of Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood ProductsMemorandum · Center for Biologics Evaluation and Research
• 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