Guidances directory

All guidance documents2,320 total

• E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening ConditionsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 398350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of AssemblyGuidance Document · Office of Regulatory Affairs
• E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 550260 Cranberry Sauce - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525425 Hops - Adulteration Involving Aphid InfestationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 300400 Contamination of Devices Labeled as SterileCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 448100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 555300 Foods, Except Dairy Products - Adulteration with SalmonellaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 345100 Condoms; Defects - Criteria for Direct Reference SeizureCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 550590 Cloudberries (Multer Berries), Canned - Adulteration by InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 355200 Electrical Muscle StimulatorsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 515100 Confectionery - Use of Non-Nutritive Substances as IngredientsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550250 Citrus Fruit Juices, Canned - Adulteration with Fly Filth and MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550235 Cherry Jam - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585225 Black-Eyed Peas (Cow Peas, Field Peas); Dried-Adulteration with Lygus Bug DamageCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 250500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices is obsolete and was withdrawn on 7/16/2018Compliance Policy Guide (CPG) · Office of Regulatory Affairs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
• 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
• 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
• 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
• 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
• 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
• Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood ProductsMemorandum · Center for Biologics Evaluation and Research
• 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
• Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care FacilitiesGuidance 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 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
• Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19Guidance Document · Center for Devices and Radiological Health
• 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 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
• Quality Assurance Guidelines for Hemodialysis DevicesGuidance Document · Center for Devices and Radiological Health
• 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
• Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)Guidance Document · Center for Devices and Radiological Health
• Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In VitroGuidance Document · Center for Drug Evaluation and Research
• 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
• 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 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
• Format and Content of the Clinical and Statistical Sections of an ApplicationGuidance Document · Center for Drug Evaluation and Research
• 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
• 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
• Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40)Guidance Document · Center for Devices and Radiological Health
• User Instructions - Multi Axis Workstations (Laser Notice 39)Guidance Document · Center for Devices and Radiological Health
• Color Additive Petitions - Medical DevicesGuidance Document · Center for Devices and Radiological Health
• Master Files Part III - Guidance on Scientific and Technical InformationGuidance Document · Center for Devices and Radiological Health
• All US Condom Manufacturers, Importers and RepackagersGuidance Document · Center for Devices and Radiological Health
• Format and Content of the Human Pharmacokinetics and Bioavailability Section of an ApplicationGuidance Document · Center for Drug Evaluation and Research
• GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTSGuidance Document · Center for Drug Evaluation and Research
• Formatting, Assembling and Submitting New Drug and Antibiotic Applications*Guidance Document · Center for Drug Evaluation and Research
• Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Policy on Lamp Compatibility (sunlamps)Guidance Document · Center for Devices and Radiological Health
• Walk-In Workstations (Laser Notice 37)Guidance Document · Center for Devices and Radiological Health
• Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp ProductsGuidance Document · Center for Devices and Radiological Health
• Policy on Warning Label Required on Sunlamp ProductsGuidance Document · Center for Devices and Radiological Health
• User Instruction Hazard Warnings (Laser Notice 35)Guidance Document · Center for Devices and Radiological Health
• Medical Laser Delivery System Interlocks (Laser Notice 34)Guidance Document · Center for Devices and Radiological Health
• Plasma Derived from Therapeutic Plasma ExchangeMemorandum · Center for Biologics Evaluation and Research
• Enforcement Policy on Marketing OTC Combination Products (CPG 7132b16)Guidance Document · Center for Drug Evaluation and Research
• Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug EstablishmentGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 450100 CGMP Enforcement Policy - OTC vs Rx DrugsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Procedures for Laboratory Testing of Microwave OvensGuidance Document · Center for Devices and Radiological Health
• Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product ManufacturersGuidance Document · Center for Devices and Radiological Health
• Investigational Medical Laser Significant Risk Device (Laser Notice 31)Guidance Document · Center for Devices and Radiological Health
• Clinical Evaluation of Antiepileptic Drugs (adults and children)Guidance Document · Center for Drug Evaluation and Research
• CPG Sec 578400 Treated Grain Seed - Mercury ResidueCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555500 All Food Sanitation (Including Bacteriological) Inspections - Classification of EstablishmentCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555450 Foods - Adulteration Involving Infestation and 1080 RodenticideCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 390100 Definition of “Commerce” - 21 CFR 10003(d) 2Compliance Policy Guide (CPG) · Center for Devices and Radiological Health
• Alternate Wording For Caution Statement (Laser Notice 30)Guidance Document · Center for Devices and Radiological Health