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
Guidance for Industry and FDA Staff - Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50)
06/24/07
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
Reporting Forms
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Content current as of:
09/27/2024