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