| 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| Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff |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| Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff |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 |
| Full Field Digital Mammography System - Class II Special Controls Guidance for Industry and FDA Staff |
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 |
| 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 |
| Procedures for Field Testing Microwave Ovens |
08/01/77 |
| 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) |
09/09/76 |
| 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 |
| Quality Control Practices for Compliance with the Federal Laser Product Performance Standard |
03/01/76 |
| 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 |
