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        Electronic Product Radiation Control Program

Electronic Product Radiation Control Program:  Industry Guidance Home
          Radiation-Emitting Products
          Electronic Product Radiation Control Program
          Electronic Product Radiation Control Program:  Industry GuidanceElectronic Product Radiation Control Program Electronic Product Radiation Control Program:  Industry Guidance
  	
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    PrintThis page contains a listing of guidances for the FDA's Electronic Product Radiation Control Program.

Radiation-Emitting Products Guidance Documents

Title
			Issued DateGuidance 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
			02/21/23Laser 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
			02/21/23Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration
			02/21/23Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment
			02/21/23Surveying, Leveling, or Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff
			01/31/22Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Guidance for Industry and Food and Drug Administration
			05/07/19Policy Clarification for Certain Fluoroscopic Equipment Requirements - Guidance for Industry and Food and Drug Administration
			05/07/19Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff
			12/19/14Full Field Digital Mammography System - Class II Special Controls Guidance for Industry and FDA Staff
			03/27/12Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
			09/30/10Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals
			03/18/10EXEMPTIONS From Electronic Product Regulations
			01/05/10Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
			12/24/08Compliance Program Guidance Manual (CPGM) 7386.001 Inspection and Field Testing of Radiation-Emitting Electronic Products
			10/31/07Guidance for Industry and FDA Staff - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
			09/25/07Guidance for Industry and FDA Staff - Compliance Guide for Cabinet X-Ray Systems
			09/19/07Guidance for Industry and FDA Staff - Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50)
			06/24/07Frequently 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)
			03/23/07Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)
			03/23/07Guidance for Industry and FDA Staff - Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54)
			01/06/06Guidance for Industry and FDA Staff: Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)
			11/06/05Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff
			09/05/03Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products; Guidance for Industry and FDA (Laser Notice No. 52)
			07/12/02Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51)
			05/27/01Date of Manufacture Label on Radiation-Emitting Consumer Electronics
			05/14/97Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49)
			09/05/96Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only)
			09/05/96Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only)
			06/06/96All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only)
			12/11/95User Instruction for Medical Products (Laser Notice 44) (PDF Only)
			08/11/95CPG 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
			03/01/95CPG 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),)
			03/01/95Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only)
			06/07/93Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)
			06/01/92Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
			03/01/89Quality Control Guide for Sunlamp Products (FDA 88-8234) (PDF Only)
			03/01/88Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)
			03/01/88Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (PDF Version)
			10/29/87User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only)
			06/24/87Policy on Lamp Compatibility (sunlamps) (PDF Only)
			09/02/86Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (PDF Only)
			08/21/86Walk-In Workstations (Laser Notice 37) (PDF Only)
			10/21/85Policy on Warning Label Required on Sunlamp Products (PDF Only)
			06/25/85User Instruction Hazard Warnings (Laser Notice 35) (PDF Only)
			02/05/85Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only)
			01/20/85Procedures for Laboratory Testing of Microwave Ovens
			10/01/81Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only)
			09/16/81Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only)
			05/18/81Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only)
			08/25/80Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard (PDF Only)
			05/01/80Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only)
			03/28/80Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (PDF Only)
			09/14/79Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only)
			11/23/77Procedures for Field Testing Microwave Ovens
			08/01/77Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only)
			03/02/77Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only)
			11/23/76Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only)
			10/14/76Remote Interlock Connectors (Laser Notice 11) (PDF Only)
			10/07/76Interlock Design (Laser Notice 12)
			09/09/76Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only)
			08/23/76Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only)
			08/05/76Quality Control Practices for Compliance with the Federal Laser Product Performance Standard
			03/01/76Laser Energy Source (Laser Notice 2) (PDF Only)
			11/21/75Notice to Industry: Information Requirements for Cookbooks and User and Service Manuals (PDF Only)
			01/20/75

Reporting Forms

Form #
			Date
			Title
			Contact Info3663
			08/01/2017
			Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)
			DRH 301-796-57903147
			08/01/2017
			Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device
			DRH 301-796-57903632
			08/01/2017
			Guide for Preparing Product Reports on Lasers and Products Containing Lasers
			DRH 301-796-57903639
			08/01/2017
			Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
			DRH 301-796-57903640
			08/01/2017
			Reporting Guide for Laser Light Shows and Displays
			DRH 301-796-57903636
			04/01/2017
			Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show
			DRH 301-796-57903630
			08/01/2017
			Guide for Preparing Product Reports on Sunlamps and Sunlamp Products
			DRH 301-796-57903631
			08/01/2017
			Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products
			DRH 301-796-57903645
			04/01/2017
			Guide for Preparing Annual Reports for Ultrasonic Therapy Products
			DRH 301-796-57902767
			08/01/2017
			Notice of Availability of Sample Electronic Product
			DRH 301-796-57903641
			04/01/2017
			Cabinet X-Ray Annual Report
			DRH 301-796-57903643
			04/01/2017
			Microwave Oven Products Annual Report
			DRH 301-796-57903646
			08/01/2017
			Mercury Vapor Lamp Products Radiation Safety Report (PDF)
			DRH 301-796-57903660
			01/01/2019
			Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF)
			DRH 301-796-5790

Resources For You

Guidance Documents (Medical Devices and Radiation-Emitting Products)
	Compliance Policy Guides for Radiation-Emitting Products

                                                                                  Content current as of:
      02/21/2023
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting Products
			     			  						              
			
			
			
			
			
			
			  
			  RadiologyElectronic Product Radiation Control Program:  Industry Guidance
 
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