Guidances directory

All guidance documents2,320 total

• Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance StandardGuidance Document · Center for Devices and Radiological Health
• Open Door Operation of Microwave Ovens as a Result of Oven MiswiringIndustry Letter · Center for Devices and Radiological Health
• Exemption of Certain Lasers Used By DOE, NOAA and US Dept of Commerce (Laser Notice 25)Memorandum · Center for Devices and Radiological Health
• General Guidelines for OTC Combination ProductsGuidance Document · Center for Drug Evaluation and Research
• Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)Guidance Document · Center for Drug Evaluation and Research
• 21 CFR 211 PREAMBLEPreamble · Department of Health and Human Services, Food and Drug Administration
• Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization DevicesGuidance Document · Center for Devices and Radiological Health
• Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22)Guidance Document · Center for Devices and Radiological Health
• Hypnotic Drugs--Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Procedures for Field Testing Microwave OvensGuidance Document · Center for Devices and Radiological Health
• Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16)Guidance Document · Center for Devices and Radiological Health
• Lasers Manufactured and Used In-House (Laser Notice 14)Guidance Document · Center for Devices and Radiological Health
• Manufacture and Certification of Laser Kits (Laser Notice 13)Guidance Document · Center for Devices and Radiological Health
• Remote Interlock Connectors (Laser Notice 11)Guidance Document · Center for Devices and Radiological Health
• Certain Military Lasers Exempt From 21 CFR 104010 & 11 (Laser Notice 9)Memorandum · Center for Devices and Radiological Health
• Viewing Optics - Sighting Telescope (Laser Notice 8)Guidance Document · Center for Devices and Radiological Health
• Quality Control Practices for Compliance with the Federal Laser Performance StandardGuidance Document · Center for Devices and Radiological Health
• Laser Energy Source (Laser Notice 2)Guidance Document · Center for Devices and Radiological Health
• Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 102040Guidance Document · Center for Devices and Radiological Health
• CPG Sec 335300 Hypnotherapy Devices - Self-Hypnotic Tape RecordingsCompliance Policy Guide (CPG) · Office of Regulatory Affairs