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Electronic Product Radiation Control Program: Industry Guidance

Electronic Product Radiation Control Program: Industry Guidance

This page contains a listing of guidances for the FDA's Electronic Product Radiation Control Program.

Radiation-Emitting Products Guidance Documents

Title Issued Date
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Guidance for Industry and Food and Drug Administration 05/07/19
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 05/07/19
Policy Clarification for Certain Fluoroscopic Equipment Requirements - Guidance for Industry and Food and Drug Administration 05/07/19
Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration 05/07/19
Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff 10/02/17
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff 04/20/16
Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) - Guidance for Industry and Food and Drug Administration Staff 02/18/15
Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff 12/19/14
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff 05/05/14
Federal Register: Laser Products; Proposed Amendment to Performance Standard 06/24/13
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System 03/27/12
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment 05/17/11
Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 11/16/10
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
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
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 06/07/07
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, MQSA Inspectors, and FDA - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12 02/02/07
Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography 10/20/06
Guidance for Industry and FDA Staff -Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes 10/20/06
Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens 10/20/06
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
Guidance for Industry and FDA Staff: Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA 09/13/05
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
Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final Guidance for Industry and FDA 11/05/01
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51) 05/27/01
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (PDF Only) 08/13/98
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. 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
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) (PDF Only) 10/13/93
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
Medications that Increase Sensitivity to Light: A 1990 Listing 12/01/90
Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (PDF Only) 12/18/89
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) 03/01/89
Low Power Laser Reporting Exemption (Laser Notice 41) (PDF Only) 08/09/88
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
Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems 12/01/85
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
Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 08/24/81
Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only) 05/18/81
Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) (PDF Only) 10/16/80
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
Emission Delay - Remote Interlock Connector (Laser Notice 21) (PDF Only) 11/11/77
Procedures for Field Testing Microwave Ovens 08/01/77
Optional Interlocks - Labeling (Laser Notice 17) (PDF Only) 03/02/77
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) (PDF Only) 09/09/76
Emission Indicator - Visibility (Laser Notice 10) (PDF Only) 08/31/76
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
Components and Repair (Laser Notice 7) (PDF Only) 06/23/76
Emission Indicators - Brightness (Laser Notice 6) (PDF Only) 06/22/76
Tabulated Values of Accessible Emission Limits for Laser Products 03/01/76
Quality Control Practices for Compliance with the Federal Laser Product Performance Standard 03/01/76
Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) (PDF Only) 11/21/75
Emission Indicators on Energy Source (Laser Notice 3) (PDF Only) 11/21/75
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

Form # Date Title Contact Info
3661 08/01/2017 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use DRH 301-796-5790
3626 08/01/2017 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components DRH 301-796-5790
3638 08/01/2017 Guide for Filling Annual Reports for X-Ray Components and Systems DRH 301-796-5790
3627 08/01/2017 Diagnostic X-Ray CT Products Radiation Safety Report DRH 301-796-5790
3663 08/01/2017 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) DRH 301-796-5790
3662 08/01/2017 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use DRH 301-796-5790
3147 08/01/2017 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device DRH 301-796-5790
3632 08/01/2017 Guide for Preparing Product Reports on Lasers and Products Containing Lasers DRH 301-796-5790
3639 08/01/2017 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 DRH 301-796-5790
3640 08/01/2017 Reporting Guide for Laser Light Shows and Displays DRH 301-796-5790
3636 04/01/2017 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show DRH 301-796-5790
3646 08/01/2017 Mercury Vapor Lamp Products Radiation Safety Report DRH 301-796-5790
3647 04/01/2017 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps DRH 301-796-5790
3630 08/01/2017 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products DRH 301-796-5790
3631 08/01/2017 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products DRH 301-796-5790
3645 04/01/2017 Guide for Preparing Annual Reports for Ultrasonic Therapy Products DRH 301-796-5790
2767 08/01/2017 Notice of Availability of Sample Electronic Product DRH 301-796-5790
3641 04/01/2017 Cabinet X-Ray Annual Report DRH 301-796-5790
3643 04/01/2017 Microwave Oven Products Annual Report DRH 301-796-5790
3644 08/01/2017 Guide for Preparing Product Reports for Ultrasonic Therapy Products DRH 301-796-5790
3646 08/01/2017 Mercury Vapor Lamp Products Radiation Safety Report (PDF) DRH 301-796-5790
3632 08/01/2017 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF) DRH 301-796-5790
3660 01/01/2019 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF) DRH 301-796-5790
3647 04/01/2017 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF) DRH 301-796-5790

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