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Form Approved OMB No. 0910-0025 Expiration Date July 31 2020 FORM FDA 3636 4/18 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products Public reporting burden for this collection of information is estimated to average 18 hours per response including the time for reviewing instructions searching existing data sources gathering and maintaining the data needed and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information including suggestions for reducing this burden to Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paper Reduction Act PRA Staff PRAStaff fda.hhs. gov Please do NOT send your completed document to this PRA Staff email address. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. This guidance was written prior to the February 27 1997 implementation of FDA s Good Guidance Practices GGP s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public* An alternative approach may be used if such approach satisfies the requirements of the applicable statute regulations or both. More industry guidance and assistance can be found at the FDA homepage see http //www. fda*gov/Radiation-EmittingProducts/. Send your completed report to CENTER FOR DEVICES AND RADIOLOGICAL HEALTH DOCUMENT MAIL CENTER WO66-G609 ATTN ELECTRONIC PRODUCT REPORTS 10903 NEW HAMPSHIRE AVENUE SILVER SPRING MD 20993-0002 Questions about reporting and suggestions for changes to this guide may be sent to the above address or may be discussed by calling 1-800-638-2041. Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products June 1983 Revised September 1995 For laser product manufacturers this guide replaces FDA 82-8127 The reporting and recordkeeping requirements contained herein have been approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1980 OMB Approval No* 0910-0025. U*S* DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Devices and Radiological Health Silver Spring MD 20993 This page is deliberately blank. Foreword The Office of Compliance Center for Devices and Radiological Health CDRH developed this guide. This guide will assist manufacturers of electronic products which emit radiation in providing adequate reporting of radiation safety testing and compliance with federal performance standards. Title 21 of the Code of Federal Regulations CFR Parts 1002 and 1003 specify Reporting and Notification requirements. Reports submitted on radiation safety of electronic products must follow the appropriate guide 21 CFR 1002. 7. If the report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of the report will receive an acknowledgment letter with the accession number we assign to the report.

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