Radiation-Emitting Products

Industry Guidance

Radiation-Emitting Products Guidance Documents

TitleOrganizationDoc #Date
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 579KB) OIR/DMGP/MPCB, OSEL 1400053 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 (PDF - 103KB) OIR 1400056 02/18/15
Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff (PDF - 59KB) OIR/DRH/MREPB 1810 12/19/14
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff OIR/DRH 1764 05/05/14
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System OSEL/DIAM OIVD/DRD 1616 03/27/12
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment OIR/DRH 1751 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 (PDF - 424KB) OIR/DMQS 1695 11/16/10
Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling OIR/DRH 1703 09/30/10
Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals OIR/DRH 1710 03/18/10
Exemptions From Electronic Product Regulations OCER/DRH 01/05/10
Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use OIR/DRH 1680 12/24/08
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions OSEL ODE/DRARD 1617 05/30/08
Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment OIR/DRH 05/15/08
Inspection and Field Testing of Radiation-Emitting Electronic Products OIR/DRH 10/31/07
Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) OIR/DRH 1639 09/25/07
Compliance Guide for Cabinet X-Ray Systems OIR/DRH 1634 09/19/07
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) OIR/DRH 1346 06/24/07
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide OIR/DMQRP 1640 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
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) OIR/DRH 1633 03/23/07
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12 OIR/DMQS 1623 02/02/07
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 OIR/DRH 1609 10/20/06
Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes OIR/DRH 1612 10/20/06
Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens OIR/DRH 1611 10/20/06
Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Guidance for FDA Staff OIR/DRH 1600 02/08/06
Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54) OIR/DRH 1592 01/06/06
Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) OIR/DRH 1565 11/06/05
Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA OIR/DMQS/PMB 6409 09/13/05
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff OIR/DRH 2619 09/05/03
Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Laser Notice No. 52) OIR/DRH 1412 07/12/02
Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final OIR/DMQS/PMB 6400 11/05/01
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) OIR/DRH 1349 05/27/01
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (PDF Only) (PDF - 231KB) OIR/DRH 1071 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) (PDF only) (PDF - 59KB) OIR/DRH 09/05/96
Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only) (PDF - 87KB) OIR/DRH 09/05/96
Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only) (PDF - 147KB) OIR/DRH 06/06/96
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only) (PDF - 123KB) OIR/DRH 12/11/95
Labeling of Laser Products (Laser Notice 45) (PDF Only) (PDF - 90KB) OIR/DRH 08/15/95
User Instruction for Medical Products (Laser Notice 44) (PDF Only) (PDF - 123KB) OIR/DRH 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) (PDF - 321KB) OIR/DRH 116 10/13/93
Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only) (PDF - 90KB) OIR/DRH 06/07/93
Compliance Guide for Laser Products (FDA 86-8260) (PDF Only) (PDF - 105KB) OIR/DRH 278 06/01/92
Medications that Increase Sensitivity to Light: A 1990 Listing (PDF - 583KB) 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) (PDF - 58KB) OIR/DRH 12/18/89
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) OIR/DRH 758 03/01/89
Imports Radiation-Producing Electronic Products (FDA 89-8008) (PDF Only) (PDF - 226KB) OIR/DRH 756 11/01/88
Low Power Laser Reporting Exemption (Laser Notice 41) (PDF Only)  (PDF - 68KB) OIR/DRH 08/09/88
Quality Control Guide for Sunlamp Products (FDA 88-8234) (PDF Only) (PDF - 4.2MB) OIR/DRH 03/01/88
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only) (PDF - 826KB) OIR/DRH 286 03/01/88
Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (PDF Version) (PDF - 194KB) OIR/DRH 10/29/87
User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only) (PDF - 102KB) OIR/DRH 06/24/87
Importation for Investigation And Evaluation (Laser Notice 38) (PDF Only) (PDF - 100KB) OIR/DRH 05/22/87
Policy on Lamp Compatibility (sunlamps) (PDF Only) (PDF - 66KB) OIR/DRH 2343 09/02/86
Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (PDF Only) (PDF - 182KB) 08/21/86
Procedures for Laboratory Compliance Testing of Television Receivers (PDF Only) (PDF - 1.1MB) OIR/DRH 945 05/01/86
Walk-In Workstations (Laser Notice 37) (PDF Only) (PDF - 86KB) OIR/DRH 10/21/85
Low Power Laser Exemption (Laser Notice 36) (PDF Only) (PDF - 101KB) OIR/DRH 08/23/85
Policy on Warning Label Required on Sunlamp Products (PDF Only) (PDF - 71KB) OIR/DRH 1343 06/25/85
User Instruction Hazard Warnings (Laser Notice 35) (PDF Only) (PDF - 63KB) OIR/DRH 02/05/85
Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only) (PDF - 90KB) OIR/DRH 01/20/85
Procedures for Laboratory Testing of Microwave Ovens (PDF - 705KB) 10/01/81
Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only) (PDF - 74KB) OIR/DRH 343 09/16/81
Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only) (PDF - 117KB) OIR/DRH 05/18/81
Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) (PDF Only) (PDF - 101KB) OIR/DRH 10/16/80
Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only) (PDF - 71KB) OIR/DRH 08/25/80
Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard (PDF Only) (PDF - 1.8MB) 05/01/80
Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only) (PDF - 178KB) OIR/DRH 646 03/28/80
Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (PDF Only) (PDF - 117KB) OIR/DRH 09/14/79
Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only) (PDF - 154KB) OIR/DRH 11/23/77
Emission Delay - Remote Interlock Connector (Laser Notice 21) (PDF Only) (PDF - 94KB) OIR/DRH 11/11/77
Procedures for Field Testing Microwave Ovens (PDF - 2.7MB) 08/01/97
Optional Interlocks - Labeling (Laser Notice 17) (PDF Only) (PDF - 96KB) OIR/DRH 03/02/77
Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only) (PDF - 84KB) OIR/DRH 03/02/77
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF Only) (PDF - 13KB) OIR/DRH 12/08/76
Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only) (PDF - 55KB) OIR/DRH 11/23/76
Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only) (PDF - 86KB) OIR/DRH 10/14/76
Remote Interlock Connectors (Laser Notice 11) (PDF Only) (PDF - 62KB) OIR/DRH 10/07/76
Interlock Design (Laser Notice 12) (PDF Only) (PDF - 264KB) OIR/DRH 09/09/76
Emission Indicator - Visibility (Laser Notice 10) (PDF Only) (PDF - 81KB) OIR/DRH 08/31/76
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only) (PDF - 90KB) OIR/DRH 08/23/76
Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only) (PDF - 71KB) OIR/DRH 08/05/76
Components and Repair (Laser Notice 7) (PDF Only) (PDF - 86KB) OIR/DRH 06/23/76
Emission Indicators - Brightness (Laser Notice 6) (PDF Only) (PDF - 55KB) OIR/DRH 06/22/76
Tabulated Values of Accessible Emission Limits for Laser Products (PDF - 1.7MB) 03/01/76
Quality Control Practices for Compliance with the Federal Laser Product Performance Standard (PDF - 1.1MB) 03/01/76
Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) (PDF Only) (PDF - 72KB) OIR/DRH 11/21/75
Emission Indicators on Energy Source (Laser Notice 3) (PDF Only) (PDF - 61KB) OIR/DRH 11/21/75
Laser Energy Source (Laser Notice 2) (PDF Only) (PDF - 40KB) OIR/DRH 11/21/75
Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 (PDF - 129KB) 08/24/81
Notifications to Industry (PDF Only) (PDF - 495KB) 01/20/75
Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems OIR/DRH 271 12/01/85

Reporting Forms

Form #DateTitleContact Info
3661 06/01/2015 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use (PDF) (PDF - 694KB) DRH
301-796-5790
3626 01/01/2014 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components (PDF) (PDF - 1.1MB) DRH
301-796-5790
3638 03/01/2014 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF) (PDF - 871KB) DRH
301-796-5790
3627 01/01/2014 Diagnostic X-Ray CT Products Radiation Safety Report (PDF) (PDF - 836KB) DRH
301-796-5790
3663 03/01/2016 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF) (PDF - 742KB) DRH
301-796-5790
3662 12/01/2015 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF) (PDF - 729KB) DRH
301-796-5790
3147 09/01/2014 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF) (PDF - 711KB) DRH
301-796-5790
3632 02/01/2013 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF) (PDF - 1MB) DRH
301-796-5790
3639 03/01/2014 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF) (PDF - 988KB) DRH
301-796-5790
3640 03/01/2014 Reporting Guide for Laser Light Shows and Displays (PDF) (PDF - 919KB) DRH
301-796-5790
3636 03/01/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF) (PDF - 811KB) DRH
301-796-5790
3646 04/01/2014 Mercury Vapor Lamp Products Radiation Safety Report (PDF) (PDF - 886KB) DRH
301-796-5790
3647 05/01/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF) (PDF - 888KB) DRH
301-796-5790
3630 10/01/2014 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (PDF) (PDF - 1.2MB) DRH
301-796-5790
3631 02/01/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF) (PDF - 823KB) DRH
301-796-5790
3645 06/01/2015 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF) (PDF - 761KB) DRH
301-796-5790
2767 05/01/2014 Notice of Availability of Sample Electronic Product (PDF) (PDF - 627KB) DRH
301-796-5790
3641 04/01/2014 Cabinet X-Ray Annual Report (PDF) (PDF - 860KB) DRH
301-796-5790
3643 03/01/2014 Microwave Oven Products Annual Report (PDF) (PDF - 865KB) DRH
301-796-5790
3644 02/01/2015 Guide for Preparing Product Reports for Ultrasonic Therapy Products (PDF) (PDF - 815KB) DRH
301-796-5790
3646 04/01/2014 Mercury Vapor Lamp Products Radiation Safety Report (PDF) (PDF - 886KB) DRH
301-796-5790
3632 02/01/2013 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF) (PDF - 1MB) DRH
301-796-5790
3660 07/01/2007 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF) (PDF - 2.5MB) DRH
301-796-5790
3647 05/01/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF) (PDF - 888KB) DRH
301-796-5790

Page Last Updated: 10/07/2015
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