Guidances directory

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All guidance documents2,854 total

Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5Guidance Document · Center for Devices and Radiological Health
510(K) Information Needed for Hydroxyapatite Coated Orthopedic ImplantsGuidance Document · Center for Devices and Radiological Health
SUPAC-IR Questions and Answers about SUPAC-IR GuidanceGuidance Document · Center for Drug Evaluation and Research
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))Guidance Document · Center for Devices and Radiological Health
Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k))Guidance Document · Center for Devices and Radiological Health
General Considerations for the Clinical Evaluation of DrugsGuidance Document · Center for Drug Evaluation and Research
CPG Sec 540.400 Shrimp - Fresh or Frozen, Raw, Headless, Peeled or Breaded (Revoked 12/24/96)Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD ProtectionGuidance Document · Center for Devices and Radiological Health
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]Guidance Document · Center for Devices and Radiological Health
Identification Labels for Certain Class I Laser Products (Laser Notice 48)Guidance Document · Center for Devices and Radiological Health
Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49)Guidance Document · Center for Devices and Radiological Health
Single Dose Acute Toxicity Testing for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
CPG Sec 540.350 Common or Usual Names for Crustaceans (Revoked 8/23/96)Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 540.300 Crabmeat - Product Name (Revoked 8/23/96)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 540.100 Capelin - Prohibited from Being Labeled as Smelt (Revoked 8/23/96)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 110.900 Imported Products - Lack of English LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
Variance from Manufacturer Report Number Format - No. 5Guidance Document · Center for Devices and Radiological Health
CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority* (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec 515.200 Malt Extract; Malt Syrup; Malted Cereal Syrup; Liquid Malt; Dried MaltCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 510.700 Fortification of Standardized JuicesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 510.450 Labeling - Diluted Wines and Cider with Less Than 7% AlcoholCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 505.400 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles (Labeling)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 500.300 "Approved by FDA" - Use of Phrase Objectionable in Marketing or Labeling of a Food AdditiveCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 500.250 Food Additives - Labeling Directions Necessary for Safe Use: CPG Sec 500.250 Food AdditivesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo UseGuidance Document · Center for Drug Evaluation and Research
CPG Sec 527200 Cheese & Cheese Products - Adulteration with FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 585675 Popcorn - Adulteration with Rodent Filth and Field CornCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 505500 Macaroni and Noodle Products - Adulteration Involving Insect Fragments and Rodent HairsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec. 160.500 Answering Inquiries on Status of Criminal ReferralsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 527.600 Use of DDVP (dichlorvos) Strips in Milkhouses and MilkroomsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 527.500 Malted MilkCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - ReconditioningCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)Memorandum · Center for Biologics Evaluation and Research
Variance from Manufacturer Report Number Format [MDR letter]Guidance Document · Center for Devices and Radiological Health
E3 Structure and Content of Clinical Study ReportsGuidance Document · Center for Drug Evaluation and Research
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsGuidance Document · Center for Drug Evaluation and Research
E4 Dose-Response Information to Support Drug RegistrationGuidance Document · Center for Drug Evaluation and Research
Effective Visual Control of Laser Projections (Laser Notice 47)Guidance Document · Center for Devices and Radiological Health
Suggested Format For IDE Progress ReportGuidance Document · Center for Devices and Radiological Health
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV): Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
S2A Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Medical Device Reporting for User FacilitiesGuidance Document · Center for Devices and Radiological Health
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived ProductsGuidance Document · Center for Drug Evaluation and Research Center for Biologics Evaluation and Research
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)Guidance Document · Center for Devices and Radiological Health
Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)Guidance Document · Center for Devices and Radiological Health
Q1B Photostability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
S1A The Need for Long-term Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsGuidance Document · Center for Drug Evaluation and Research
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)Industry Letter · Center for Devices and Radiological Health
Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated PlasmapheresisMemorandum · Center for Biologics Evaluation and Research
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationGuidance Document · Center for Drug Evaluation and Research
Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care FacilitiesGuidance Document · Center for Devices and Radiological Health
User Instruction for Medical Products (Laser Notice 44)Guidance Document · Center for Devices and Radiological Health
Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen: Memorandum to All Registered Blood EstablishmentsMemorandum · Center for Biologics Evaluation and Research
Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)Guidance Document · Center for Devices and Radiological Health
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesGuidance Document · Center for Devices and Radiological Health
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling DevicesGuidance Document · Center for Devices and Radiological Health
Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise EquipmentGuidance Document · Center for Devices and Radiological Health
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsGuidance Document · Center for Biologics Evaluation and Research
Testing Guidance for Male Condoms Made From New Material (Non-Latex)Guidance Document · Center for Devices and Radiological Health
Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy WrappersIndustry Letter · Human Foods Program
CPG Sec 100.900 International Memoranda of UnderstandingCompliance Policy Guide (CPG) · Center for Veterinary Medicine Human Foods Program Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Tobacco Products
Guidance on the Content and Organization of a Premarket Notification for a Medical LaserGuidance Document · Center for Devices and Radiological Health
Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant ComponentsGuidance Document · Center for Devices and Radiological Health
Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors: Memorandum to Licensed EstablishmentsMemorandum · Center for Biologics Evaluation and Research
CPG Sec. 625.500 Failure to Register *and/or Drug List* (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for *Warning* Letter Issuance (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 370.100 Cytotoxic Testing for Allergic DiseasesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 345.300 Menstrual SpongesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug UseGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity PreparationsGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination ProductsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and EffectiveGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and ClaimsGuidance Document · Center for Drug Evaluation and Research
CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory ActionCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec. 400.500 Identical or Similar Product NamesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec. 400.200 Consistent Application of CGMP DeterminationsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec 587.200 Uncertified or Delisted Colors in Foods for Export - (e.g., FD&C Red #2)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 355.300 Ion Generating DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec 515.600 Candied Citron - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 515.400 Raw SugarCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 500.400 Use of Calcium Chloride as a Drying Agent in Such Products as Packaged Potato Chips and PeanutsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec. 231.130- Storage of *Platelets* [ ] for up to five (5) Days is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 231.120- Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing *Platelets* and Fresh Frozen Plasma* is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 231.100- *Platelets, Pooled* is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG 230.130- Adequate Space for Determination of Donor Suitability (Obsolete, Withdrawn on 7/16/2018)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 550270 Currants - Adulteration Involving Wormy FruitsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 550450 Jam, Black Currant - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 480300 Lack of Expiration Date of Stability DataCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 575100 Pesticide Residues in Food and Feed - Enforcement CriteriaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 400100 Drugs, Human - Failure to RegisterCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
Q2A Text on Validation of Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research