FDA一般要三套文件和一个登记。

1. 据FDA的规定，生产公司要在FDA登记, 找一个美国代理(US FDA Agent). FDA一般要给美国代理打电话，发邮件， 要通过美国代理负责跟国内厂家沟通。我们作为专业代理， 代理费用第一年$399, 以后每一年$299代理费.

2. 国内厂家主要要递交三套文件

第一套是“产品报告”， 表格有20多页要填，且要提供，产品说明书，维修手册，激光参数， 工作流程图，工作原理图等很多英文版文件。 总共下来要几十页。国内厂家要提供这些。

第二套文件是“年报”也有更多材料要提供。

第三套文件是“产品”参数和安全测试报告。要自我认证。保证产品符合FDA标准。
能量输出要小于 5 milliwatts，可视光波长要在400 至710 nanometers。

这三套文件费用, 美国要几千美元。我们建议国内厂家最好要我们深圳代理商做. 我们的代理商，可以做产品测试，产品 “参数和安全测试报告”, “产品报告”. 测试和报告费用通常为RMB5000左右.

医疗用激光产品，一般还要另外递交510K，FDA收审阅费 4158美元。510K要60-90天才能审阅完。所有整个申请要3-5个月以上。普通激光产品， 不必提交510K。

Laser products are subject to the reporting requirements in 21 CFR 1002 and are required to be certified (21 CFR 1010) and comply with the laser product performance standard (21 CFR 1040.10).

The FDA has developed a mandatory performance standard for all laser products that are marketed in the United States. Please see the FDA home page for radiation-emitting products at: www.FDA.gov/FDA/comp/eprc.html On this page you can read the Federal regulations that cover reporting requirements (see 21 CFR 1002.10) and the laser product performance standard (see 21 CFR 1040.10). If you select a product area, such as Consumer Products, you can see a list of documents on the right side, many of which you should become familiar with. The Laser Reporting Guide (Radiation Safety Product Report) must be completed for each laser product and submitted to the FDA office to demonstrate that your laser products comply with the FDA's laser performance standard. An Annual Report is required each year.

There are also numerous Notices to Industry, several of which pertain to industrial lasers, the IEC standard (Laser Notice 50), and importation procedures.

A complete Product Report is required for each laser product model or model family.
Product Reports were formerly called Initial or Model Change Reports. FDA suggests that a complete report on one model of a family be submitted, with a separate Supplemental Report for each of the other models in the family. The Supplemental Report should respond in detail to the parts of the guide where there are differences to report, referencing the number of the affected item.

A new or modified model belonging to a previously reported model family must be reported in a Supplemental Report on that model family prior to its introduction into commerce.

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. Reference this accession number in the future when providing additional information about this model family in either a supplement or the annual report. If a report is incomplete or inadequate FDA may reject it and return it for completion. FDA will not enter a rejected report into FDA database. Also, a rejected report will not receive an accession number.

FDA DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer's responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing practices.

Prior to the shipment of products into the US, 21 CFR 1002 requires the manufacturer to submit the report and to comply with all applicable importation requirements
(21 CFR 1005). If there are deficiencies, FDA may disapprove the firm's quality control and testing program, determine that the product FDA will notify the manufacturer if FDA make such a determination. FDA may require the manufacturer to cease introduction into U.S. commerce until deficiencies are corrected, and to initiate a corrective action program (21 CFR 1003 -1004) for products already introduced into commerce

When a company submit the Laser Radiation Safety Product report, a unique Accession Number will be assigned to the report and a letter or message will be sent to the company with this number. This number, along with some description of the product, should be included on the FD 2877 imports form and presented to Customs at the American port of entry. Customs can check with FDA as to the status of the documentation and will release the Shipment if everything is in order.

Please note, certain Class I laser products are exempted from "product report”:

• Class I optical disc products, such as CD or DVD players, readers, or recorders, whether the products are stand-alone units, installed into other systems (such as computers or automobiles), or intended to be installed into other systems, and
• Class I laser products intended for home or office use, such as laser printers, that totally enclose any laser radiation that they generate, and in addition
• Any laser products that do not by virtue of their design allow human access to laser radiation in excess of the accessible emission limits of Class I specified in 21 CFR 1040.10(d), as determined in accordance with 21 CFR 1040.10(e), under any condition of operation, maintenance, service, or failure.

When new models of a laser product are introduced, if the models satisfy the criteria for an established reporting exemption or if the new models do not involve changes in radiation emission or performance requirements, then the manufacturer need not report the models prior to introduction into commerce. Rather, the manufacturer is only required to identify them in the annual report, or in quarterly updates to the annual report. Quarterly updates to annual reports should be clearly marked as such and be submitted prior to December 1, March 1, and/or June 1 when required. [See 21 CFR 1002.13(c).

Labeling:
Laser products should have certification and identification labels (shown below) stating the product complies with the federal laser standard.

Products should have a warning label (shown below) advising the user to avoid exposure to the laser radiation.