Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment
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OCER/DMQRP
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1751
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05/17/11
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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)
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OCER/DMQRP
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1695
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11/16/10
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Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
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OCER/DMQRP/EPB
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1703
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09/30/10
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Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals
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OCER/DMQRP/EPB
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03/18/10
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Exemptions From Electronic Product Regulations
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OCER/DMQRP/EPB
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01/05/10
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Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
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OCER/DMQRP
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1680
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12/24/08
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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment
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Compliance Program Guidance Manual for Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment
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05/15/08
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Inspection and Field Testing of Radiation-Emitting Electronic Products
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Compliance Program Guidance Manual 7386.001 for Inspection and Field Testing of Radiation-Emitting Electronic Products
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10/31/07
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Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
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OCER/DMQRP
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1639
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09/25/07
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Compliance Guide for Cabinet X-Ray Systems
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OCER/DMQRP
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1634
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09/19/07
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Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50)
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OCER/DMQRP
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1346
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06/24/07
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Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
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OCER/DMQRP
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1640
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06/07/07
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Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)
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OCER/DMQRP
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1633
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03/23/07
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The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12
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OCER/DMQRP
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1623
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02/02/07
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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
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OCER/DMQRP
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1609
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10/20/06
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Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes
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OCER/DMQRP
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1612
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10/20/06
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Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens
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OCER/DMQRP
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1611
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10/20/06
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Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54)
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OCER/DMQRP
OCER/DMQRP/EPDB
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1592
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01/06/06
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Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)
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OCER/DMQRP/EPDB
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1565
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11/06/05
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Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA
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OCER/DMQRP/ICB
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6409
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09/13/05
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Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Laser Notice No. 52)
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OCER/DMQRP
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1412
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07/12/02
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Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final
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OCER/DMQRP/ICB
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6400
|
11/05/01
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Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)
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OCER/DMQRP/EPDB
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1349
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05/27/01
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Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (PDF Only) (PDF - 231KB)
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OCER/DMQRP
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1071
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08/13/98
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Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) (PDF only) (PDF - 59KB)
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OCER/DMQRP
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09/05/96
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Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only) (PDF - 87KB)
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OCER/DMQRP
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09/05/96
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Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only) (PDF - 147KB)
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OCER/DMQRP
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06/06/96
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All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only) (PDF - 123KB)
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OCER/DMQRP
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12/11/95
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Labeling of Laser Products (Laser Notice 45) (PDF Only) (PDF - 90KB)
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OCER/DMQRP
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08/15/95
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User Instruction for Medical Products (Laser Notice 44) (PDF Only) (PDF - 123KB)
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OCER/DMQRP
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08/11/95
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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)
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OCER/DMQRP/DDB
|
116
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10/13/93
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Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only) (PDF - 90KB)
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OCER/DMQRP
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06/07/93
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Compliance Guide for Laser Products (FDA 86-8260) (PDF Only) (PDF - 105KB)
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OCER/DMQRP/EPDB
|
278
|
06/01/92
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Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (PDF Only) (PDF - 58KB)
|
OCER/DMQRP
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12/18/89
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Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
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OCER/DMQRP
|
758
|
03/01/89
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Imports Radiation-Producing Electronic Products (FDA 89-8008) (PDF Only) (PDF - 226KB)
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OCER/DMQRP/EPDB
|
756
|
11/01/88
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Low Power Laser Reporting Exemption (Laser Notice 40) (PDF Only) (PDF - 68KB)
|
OCER/DMQRP
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|
08/09/88
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Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only) (PDF - 826KB)
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OCER/DMQRP/EPDB
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286
|
03/01/88
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User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only) (PDF - 102KB)
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OCER/DMQRP
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06/24/87
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Importation for Investigation And Evaluation (Laser Notice 38) (PDF Only) (PDF - 100KB)
|
OCER/DMQRP
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05/22/87
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Policy on Lamp Compatibility (sunlamps) (PDF Only) (PDF - 66KB)
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OCER/DMQRP/EPDB
|
2343
|
09/02/86
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Procedures for Laboratory Compliance Testing of Television Receivers (PDF Only) (PDF - 1.1MB)
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OCER/DMQRP/EPDB
|
945
|
05/01/86
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Walk-In Workstations (Laser Notice 37) (PDF Only) (PDF - 86KB)
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OCER/DMQRP
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10/21/85
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Low Power Laser Exemption (Laser Notice 36) (PDF Only) (PDF - 101KB)
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OCER/DMQRP
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08/23/85
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Policy on Warning Label Required on Sunlamp Products (PDF Only) (PDF - 71KB)
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OCER/DMQRP/EPDB
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1343
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06/25/85
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User Instruction Hazard Warnings (Laser Notice 35) (PDF Only) (PDF - 63KB)
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OCER/DMQRP
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02/05/85
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Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only) (PDF - 90KB)
|
OCER/DMQRP
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01/20/85
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Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only) (PDF - 74KB)
|
OCER/DMQRP/EPDB
|
343
|
09/16/81
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Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only) (PDF - 117KB)
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OCER/DMQRP
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05/18/81
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Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) (PDF Only) (PDF - 101KB)
|
OCER/DMQRP
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10/16/80
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Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only) (PDF - 71KB)
|
OCER/DMQRP
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08/25/80
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Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only) (PDF - 178KB)
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OCER/DMQRP/EPDB
|
646
|
03/28/80
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Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (PDF Only) (PDF - 117KB)
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OCER/DMQRP
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09/14/79
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Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only) (PDF - 154KB)
|
OCER/DMQRP
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11/23/77
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Emission Delay - Remote Interlock Connector (Laser Notice 21) (PDF Only) (PDF - 94KB)
|
OCER/DMQRP
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11/11/77
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Optional Interlocks - Labeling (Laser Notice 17) (PDF Only) (PDF - 96KB)
|
OCER/DMQRP
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03/02/77
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Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only) (PDF - 84KB)
|
OCER/DMQRP
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03/02/77
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Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF Only) (PDF - 13KB)
|
OCER/DMQRP
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12/08/76
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Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only) (PDF - 55KB)
|
OCER/DMQRP
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11/23/76
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Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only) (PDF - 86KB)
|
OCER/DMQRP
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10/14/76
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Remote Interlock Connectors (Laser Notice 11) (PDF Only) (PDF - 62KB)
|
OCER/DMQRP
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10/07/76
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Interlock Design (Laser Notice 12) (PDF Only) (PDF - 264KB)
|
OCER/DMQRP
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09/09/76
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Emission Indicator - Visibility (Laser Notice 10) (PDF Only) (PDF - 81KB)
|
OCER/DMQRP
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08/31/76
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Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only) (PDF - 90KB)
|
OCER/DMQRP
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08/23/76
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Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only) (PDF - 71KB)
|
OCER/DMQRP
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08/05/76
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Components and Repair (Laser Notice 7) (PDF Only) (PDF - 86KB)
|
OCER/DMQRP
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06/23/76
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Emission Indicators - Brightness (Laser Notice 6) (PDF Only) (PDF - 55KB)
|
OCER/DMQRP
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06/22/76
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Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) (PDF Only) (PDF - 72KB)
|
OCER/DMQRP
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11/21/75
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Emission Indicators on Energy Source (Laser Notice 3) (PDF Only) (PDF - 67KB)
|
OCER/DMQRP
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11/21/75
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Laser Energy Source (Laser Notice 2) (PDF Only) (PDF - 40KB)
|
OCER/DMQRP
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11/21/75
|
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff
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Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 (PDF - 129KB)
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