now we need to generate a product report refer to guideline 1002.10 of FDA
To generate a product report in reference to guideline 1002. of the FDA, you will need to ensure that the report contains specific elements as outlined in the guideline. These may include details about the product, its intended use, its manufacturing process, ingredients, labeling, any adverse events or complaints related to the product, and any recalls or corrective actions taken. It's important to carefully review the specific requirements laid out in the guideline to ensure that all necessary information is included in the report. If you can provide more specific details about the product and the guideline requirements, I can assist you further in generating the report.
the guidelines are listed:
I'm here to help. Please go ahead and list the guidelines and I can assist you with creating the product report according to the specific requirements laid out in guideline 1002.10 of the FDA.
(a) Identify which listed product is being reported.
(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling to enable the Director to determine the place of manufacture.
(c) Include information on all components and accessories provided in, on, or with the listed product that may affect the quantity, quality, or direction of the radiation emissions.
(d) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product.
(e) State the standard or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a Federal standard, if applicable.
(f) For each model, describe the physical or electrical characteristics, such as shielding or electronic circuitry, incorporated into the product in order to meet the standards or specifications reported pursuant to paragraph (e) of this section.
(g) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures.
(h) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing of each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary.
(i) Provide sufficient results of the testing, measuring, and quality control procedures described in accordance with paragraphs (g) and (h) of this section to enable the Director to determine the effectiveness of those test methods and procedures.
(j) Report for each model all warning signs, labels, and instructions for installation, operation, and use that relate to electronic product radiation safety.
(k) Provide, upon request, such other information as the Director may reasonably require to enable him/her to determine whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Director to carry out the purposes of the Act.
To generate a comprehensive product report in accordance with guideline 1002.10 of the FDA, the following steps can be taken to address each requirement:
(a) Identify which listed product is being reported.
(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling to enable the Director to determine the place of manufacture.
(c) Include information on all components and accessories provided in, on, or with the listed product that may affect the quantity, quality, or direction of the radiation emissions.
(d) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product.
(e) State the standard or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a Federal standard, if applicable.
(f) For each model, describe the physical or electrical characteristics, such as shielding or electronic circuitry, incorporated into the product in order to meet the standards or specifications reported pursuant to paragraph (e) of this section. Provide a detailed account of the physical and electrical characteristics integrated into each model to compliance with the standards and specifications related to electronic product radiation safety.
(g) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures.
(h) For those products which may produce increased radiation aging, describe the methods and procedures used, and frequency of testing of each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary.
(i) Provide sufficient results of the testing, measuring, and quality control procedures described in accordance with paragraphs (g) and (h) of this section to the Director to determine the effectiveness of those test methods and procedures.
(j) Report for each model all warning signs, labels, and instructions for installation, operation, and use that relate to electronic radiation safety.
(k) Provide, upon request, such other information as the Director may reasonably require to enable him/her to whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Director to carry out the purposes of the Act.
This comprehensive approach ensures that the product report complies with all the specific requirements outlined in guideline 1002.10 of the FDA, enabling accurate and thorough assessment by the regulatory authority.
translate to chinese
Certainly! Here is the translation of the comprehensive approach for the product report in Chinese:
(a) 确定所报告的列出的产品。
(b) 识别列出产品的每个型号及其附带足够信息的制造商代码或其他标签系统,以便主管确定制造地点。
(c) 包括列出产品中、上或附带的可能影响辐射排放量、质量或方向的所有组件和附件的信息。
(d) 描述所报告的每个型号的功能、影响辐射排放的操作特性,以及已知使用及意图。
(e) 对每个型号的标准或设计规范陈述,涉及电子产品辐射安全。如适用,可以参考联邦标准。
(f) 对于每个型号,描述集成到产品中以符合根据本节第(e)段报道的标准或规范的物理或电气特性,如屏蔽或电子电路。
(g) 描述所使用的测试和测量方法和程序,若有的话,相关于电子产品辐射安全,包括控制不必要、次要或泄漏的电子产品辐射,用于每个型号的适用质量控制程序,以及选择这些测试和质量控制程序的基础。
(h) 对于那些可能随着老化产生增加辐射的产品,描述用于耐久性和稳定性测试的方法和程序,以及每个型号的测试频率,关于电子产品辐射安全。包括选择这些方法和程序的基础,或确定这些测试和质量控制程序无需进行的根据。
(i) 提供所述的测试、测量和质量控制程序的足够结果,以便主管确定这些测试方法和程序的有效性。
(j) 对于每个型号,列出所有关于电子产品辐射安全的警示标志、标签和安装、操作和使用说明。
(k) 根据主管合理需求,提供其他信息,以使其能够确定制造商是否已或正在依法和法规标准的规定行事,并使其能够实施法律的目的。
This translation should accurately convey the comprehensive approach for the product report in Chinese. If you need further assistance with translation or anything else, feel free to ask!