OCER Guidance Documents

Title	Organization	Doc #	Date
Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13	OCER/DMQRP	1695	10/09/09
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	OCER/DMQRP/RPB		05/15/08
Medical Glove Guidance Manual	OCER/DSMICA	1661	01/22/08
Inspection and Field Testing of Radiation-Emitting Electronic Products	OCER/DMQRP		10/31/07
Impact-Resistant Lenses: Questions and Answers	OCER/DSMICA	23	10/26/07
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
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)	OCER/DHC	1645	07/19/07
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
Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device			05/01/07
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
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
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
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment	OSB/DPS OCER/DHC	1537	03/10/06
Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Guidance for FDA Staff	OCER/DMQRP	1600	02/08/06
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
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems	OCER/DMQRP/DDB	2619	09/05/03
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions	OCER/DHC	1427	07/16/03
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
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry and FDA Staff	OCER/DHC	1408	07/09/02
Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final	OCER/DMQRP/ICB	6400	11/05/01
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff	OCER/DHC	1333	07/06/01
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)	OCER/DMQRP/EPDB	1349	05/27/01
Guidance on Medical Device Patient Labeling	OCER/DHC	1128	04/19/01
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff	OCER/DHC	1323	02/09/01
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties	OCER/DSMICA	1160	02/02/01
Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations		1173	09/27/00
Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management	OCER/DHC	1497	07/18/00
Regulation of Medical Devices: Background Information for International Officials	OCER/DSMICA	610	04/14/99
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (PDF Only)	OCER/DMQRP	1071	08/13/98
Overview of FDA Modernization Act of 1997, Medical Device Provisions	OCER/DSMICA	1174	02/19/98
Medical Device Appeals and Complaints: A Guidance on Dispute Resolution (PDF Only)	OCER/DSMICA	396	02/19/98
FDA Modernization Act of 1997 - Guidance for the Device Industry on Implementation of Highest Priority Provisions	OCER	434	02/06/98
Medical Device Reporting for Manufacturers	OCER/DSMICA	987	03/01/97
Human Factors Points to Consider for IDE Devices	OCER/DHC	839	01/17/97
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions	OCER/DSMICA	471	01/01/97
Do It By Design - An Introduction to Human Factors in Medical Devices	OCER/DHC	995	12/01/96
Medical Device Quality Systems Manual	OCER/DSMICA	6303	12/01/96
Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) (PDF only)	OCER/DMQRP		09/05/96
Identification Labels for Certain Class I Laser Products (Laser Notice 48) (PDF Only)	OCER/DMQRP		09/05/96
Effective Visual Control of Laser Projections (Laser Notice 47) (PDF Only)	OCER/DMQRP		06/06/96
Medical Device Reporting for User Facilities (PDF Only)	OCER/DHC		04/01/96
A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use	OCER/DMQRP/DDB	977	03/01/96
A Guide For The Submission Of An Abbreviated Initial Report On X-Ray Tables, Cradles, Film Changers Or Cassette Holders Intended For Diagnostic Use (PDF Only)	OCER/DMQRP/DDB	978
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) (PDF Only)	OCER/DMQRP		12/11/95
Guide for Preparing Product Reports for Lasers and Products Containing Lasers (PDF Only)	OCER/DMQRP/EPDB	277	09/01/95
Labeling of Laser Products (Laser Notice 45) (PDF Only)	OCER/DMQRP		08/15/95
User Instruction for Medical Products (Laser Notice 44) (PDF Only)	OCER/DMQRP		08/11/95
Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)- E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems (PDF Only)	OCER/DMQRP/EPDB	236	08/01/95
Certification Statement for the Impact Resistance Test (PDF Only)	OCER/DSMICA	1460	10/25/93
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) (PDF Only)	OCER/DMQRP/DDB	116	10/13/93
Human Factors Principles for Medical Device Labeling (PDF Only)	OCER/DHC	227	09/01/93
Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (PDF Only)	OCER/DMQRP		06/07/93
Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)	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)	OCER/DMQRP		12/18/89
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF Only)	OCER/DSMICA	470	09/01/89
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)	OCER/DMQRP/EPDB	756	11/01/88
Low Power Laser Reporting Exemption (Laser Notice 40) (PDF Only)	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)	OCER/DMQRP/EPDB	286	03/01/88
Impact Resistant Lenses: Questions and Answers (FDA 87-4002) (PDF Only)	OCER/DSMICA	23	09/01/87
User Instructions - Multi Axis Workstations (Laser Notice 39) (PDF Only)	OCER/DMQRP		06/24/87
Importation for Investigation And Evaluation (Laser Notice 38) (PDF Only)	OCER/DMQRP		05/22/87
Policy on Lamp Compatibility (sunlamps) (PDF Only)	OCER/DMQRP/EPDB	2343	09/02/86
Procedures for Laboratory Compliance Testing of Television Receivers (PDF Only)	OCER/DMQRP/EPDB	945	05/01/86
Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems	OCER/DMQRP/DDB	271	12/01/85
Walk-In Workstations (Laser Notice 37) (PDF Only)	OCER/DMQRP		10/21/85
Low Power Laser Exemption (Laser Notice 36) (PDF Only)	OCER/DMQRP		08/23/85
Policy on Warning Label Required on Sunlamp Products (PDF Only)	OCER/DMQRP/EPDB	1343	06/25/85
User Instruction Hazard Warnings (Laser Notice 35) (PDF Only)	OCER/DMQRP		02/05/85
Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF Only)	OCER/DMQRP		01/20/85
A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components	OCER/DMQRP/DDB	257	01/01/82
Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (PDF Only)	OCER/DMQRP/EPDB	343	09/16/81
Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 (PDF Only)	OCER/DMQRP/EPDB	880	08/24/81
Investigational Medical Laser Significant Risk Device (Laser Notice 31) (PDF Only)	OCER/DMQRP		05/18/81
Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) (PDF Only)	OCER/DMQRP		10/16/80
Alternate Wording For Caution Statement (Laser Notice 30) (PDF Only)	OCER/DMQRP		08/25/80
Guide for the filing of Annual Reports for X-Ray Components and Systems (PDF Only)	OCER/DMQRP/EPDB	253	07/01/80
Open Door Operation of Microwave Ovens as a Result of Oven Miswiring (PDF Only)	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)	OCER/DMQRP		09/14/79
Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (PDF Only)	OCER/DMQRP		11/23/77
Emission Delay - Remote Interlock Connector (Laser Notice 21) (PDF Only)	OCER/DMQRP		11/11/77
Optional Interlocks - Labeling (Laser Notice 17) (PDF Only)	OCER/DMQRP		03/02/77
Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (PDF Only)	OCER/DMQRP		03/02/77
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF Only)	OCER/DMQRP		12/08/76
Lasers Manufactured and Used In-House (Laser Notice 14) (PDF Only)	OCER/DMQRP		11/23/76
Manufacture and Certification of Laser Kits (Laser Notice 13) (PDF Only)	OCER/DMQRP		10/14/76
Remote Interlock Connectors (Laser Notice 11) (PDF Only)	OCER/DMQRP		10/07/76
Interlock Design (Laser Notice 12) (PDF Only)	OCER/DMQRP		09/09/76
Emission Indicator - Visibility (Laser Notice 10) (PDF Only)	OCER/DMQRP		08/31/76
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (PDF Only)	OCER/DMQRP		08/23/76
Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF Only)	OCER/DMQRP		08/05/76
Components and Repair (Laser Notice 7) (PDF Only)	OCER/DMQRP		06/23/76
Emission Indicators - Brightness (Laser Notice 6) (PDF Only)	OCER/DMQRP		06/22/76
Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) (PDF Only)	OCER/DMQRP		11/21/75
Emission Indicators on Energy Source (Laser Notice 3) (PDF Only)	OCER/DMQRP		11/21/75
Laser Energy Source (Laser Notice 2) (PDF Only)	OCER/DMQRP		11/21/75
COMPARISON CHART: 1996 QUALITY System Regulation Versus 1978 GOOD Manufacturing Practices Regulation Versus ANSIIISOIASQC Q9001-1994 AND ISO/DIS 13485:1996 (PDF Version)	OCER/DSMICA	133