An Overview of Manufacturer’s Responsibilities for Laser Products
激光产品制造商对激光产品所负责任的概述
This document summarizes your responsibilities as a laser manufacturer under the Code of Federal Regulations Title 21 Subchapter J (parts 1000 to 1040). It explains the performance, labeling, manufacturing, quality assurance, record keeping and reporting requirements of the laser regulations and performance standard. This document does not replace the federal regulations. Regulation under Title 21 of the Code of Federal Regulations (CFR), are cited in brackets like this: [21 CFR XXXX.XX(X)]. The website of 21 CFR is http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1040.
此文件总结了您作为激光产品制造商根据美国联邦法规21第J章(1000至1040节) 所负的责任. 此文件解释了关于性能, 标签, 生产制造, 保证, 记录保存, 和报告激光法规和性能的要求. 此文件并不取代联邦法规. 本文中联邦法规21是这样引用的: [21 CFR XXXX.XX(X)]. 联邦法规21的网站是 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1040.
Additional information is at the Food and Drug Administration’s (FDA) website: http://www.fda.gov/Radiation-EmittingProducts/default.htm .
关于更多信息，请参考美国食品和局（FDA）的网站: http://www.fda.gov/Radiation-EmittingProducts/default.htm .
Guidance for industry on getting a radiation emitting product to market is here: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/ucm202505.htm
关于FDA给与工业界关于辐射产品的指导意见, 请参考: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/ucm202505.htm
SUMMARY
摘要
A manufacturer is any person or organization in the business of manufacturing [21 CFR 1003(n)] laser products. The US imports regulations do not allow noncompliant or non-certified products to be imported into the US for sales. This means that the person manufacturing laser products for sale in the United States is responsible for ensuring that the laser products comply with federal regulations.
一个制造商是任何人或组织从事制造业务[21 CFR 1003(n)], 组装[21 CFR 1003(n)], 进口[21 CFR 1000.3(f)], 或修改[21 CFR 1040.10(i)]激光产品. 美国进口法规不允许不符合要求或非认证产品进口到美国销售. 这意味着在美国销售的激光产品的制造商要负责确保激光产品符合美国联邦法规.
A manufacturer of laser products for sale in the United States must:
在美国销售激光产品的制造商必须：
1. Design and manufacture their products to be compliant with the laser performance standard [21 CFR 1040.10 and 1040.11].
1. 设计和制造符合激光性能的产品 [21 CFR 1040.10 and 1040.11].
2
2. Certify that their products comply with the laser performance standard [21 CFR 1010.2].
2. 认证其产品符合激光性能 [21 CFR 1010.2].
3. their products for compliance with the laser performance standard [21 CFR 1010.2(c)].
3. 你们的产品符合激光性能[21 CFR 1010.2(c)].
4. Maintain test, distribution, and correspondence records concerning radiation safety, safety complaints, and inquiries [21 CFR 1002.30 to 1002.42].
4. 保留关于辐射, 投诉, 以及查询的, 分销, 和信件记录 [21 CFR 1002.30 to 1002.42].
5. Report accidental radiation occurrences to FDA [21 CFR 1002.20].
5. 向FDA报告辐射意外事件[21 CFR 1002.20].
6. Submit reports to FDA, including Laser Product Reports [21 CFR 1002.10], which describe compliance of the product design and testing program, and Annual Reports [21 CFR 1002.13], which summarize required records.
6. 向FDA提交报告, 其中包括描述产品设计和程序合规性的激光产品报告[21 CFR 1002.10], 以及汇总所需记录的年度报告 [21 CFR1002.13].
7. Notify FDA of defects with the laser product or failures of the laser product to comply with the laser performance standard [21 CFR 1003.10].
7. 通知FDA激光产品的缺陷或故障以遵循激光的性能[21 CFR 1003.10].

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