This page contains a listing of guidances for the FDA's Electronic Product Radiation Control Program.
Radiation-Emitting Products Guidance Documents Title Issued Date Guidance for Industry and FDA Staff - Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide 02/21/23 Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration 02/21/23 Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration 02/21/23 Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment 02/21/23 Surveying, Leveling, or Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff 01/31/22 Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Guidance for Industry and Food and Drug Administration 05/07/19 Policy Clarification for Certain Fluoroscopic Equipment Requirements - Guidance for Industry and Food and Drug Administration 05/07/19 Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff 12/19/14 Full Field Digital Mammography System - Class II Special Controls Guidance for Industry and FDA Staff 03/27/12 Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling 09/30/10 Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals 03/18/10 EXEMPTIONS From Electronic Product Regulations 01/05/10 Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use 12/24/08 Compliance Program Guidance Manual (CPGM) 7386.001 Inspection and Field Testing of Radiation-Emitting Electronic Products 10/31/07 Guidance for Industry and FDA Staff - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) 09/25/07 Guidance for Industry and FDA Staff - Compliance Guide for Cabinet X-Ray Systems 09/19/07 Frequently Asked Questions Regarding the Laser Notice 53 - Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (issued March 23, 2007) 03/23/07 Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) 03/23/07 Guidance for Industry and FDA Staff - Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54) 01/06/06 Guidance for Industry and FDA Staff: Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) 11/06/05 Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff 09/05/03 Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products; Guidance for Industry and FDA (Laser Notice No. 52) 07/12/02 Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51) 05/27/01 Date of Manufacture Label on Radiation-Emitting Consumer Electronics 05/14/97 Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) 09/05/96 Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only) 09/05/96 Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only) 06/06/96 All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only) 12/11/95 User Instruction for Medical Products (Laser Notice 44) (PDF Only) 08/11/95 CPG Sec 394.100 Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002; Retention of Microwave Oven Test Records 03/01/95 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),) 03/01/95 Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only) 06/07/93 Compliance Guide for Laser Products (FDA 86-8260) (PDF Only) 06/01/92 Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment 09/27/24 Quality Control Guide for Sunlamp Products (FDA 88-8234) (PDF Only) 03/01/88 Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only) 03/01/88 Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (PDF Version) 10/29/87 User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only) 06/24/87 Policy on Lamp Compatibility (sunlamps) (PDF Only) 09/02/86 Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (PDF Only) 08/21/86 Walk-In Workstations (Laser Notice 37) (PDF Only) 10/21/85 Policy on Warning Label Required on Sunlamp Products (PDF Only) 06/25/85 User Instruction Hazard Warnings (Laser Notice 35) (PDF Only) 02/05/85 Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only) 01/20/85 Procedures for Laboratory Testing of Microwave Ovens 10/01/81 Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only) 09/16/81 Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only) 05/18/81 Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only) 08/25/80 Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard (PDF Only) 05/01/80 Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only) 03/28/80 Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (PDF Only) 09/14/79 Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only) 11/23/77 Procedures for Field Testing Microwave Ovens 08/01/77 Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only) 03/02/77 Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only) 11/23/76 Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only) 10/14/76 Remote Interlock Connectors (Laser Notice 11) (PDF Only) 10/07/76 Interlock Design (Laser Notice 12) 09/09/76 Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only) 08/23/76 Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only) 08/05/76 Quality Control Practices for Compliance with the Federal Laser Product Performance Standard 03/01/76 Laser Energy Source (Laser Notice 2) (PDF Only) 11/21/75 Notice to Industry: Information Requirements for Cookbooks and User and Service Manuals (PDF Only) 01/20/75
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Content current as of:
12/31/2024
