眼镜出口美国FDA认证全流程指南 - 含落球测试要求
眼镜产品概述/Eyeglasses Product Overview:
眼镜是镶嵌在框架内的透镜镜片，戴在眼睛前方，以改善视力、保护眼睛或作装饰用途。可矫正多种视力问题，包括近视、远视、散光、老花或斜视、弱视等。
Eyeglasses are lens-mounted frames worn in front of the eyes to improve vision, protect eyes or for decorative purposes. They can correct various vision problems including myopia, hyperopia, astigmatism, presbyopia or strabismus, amblyopia, etc.
FDA认证必要性/FDA Certification Requirements:
眼镜出口美国必须办理FDA注册（510k豁免类型）。除隐形眼镜外，包括太阳镜都属于医疗器械I类产品范围。
Eyeglasses exported to the US must obtain FDA registration (510k exempt type). Except for contact lenses, including sunglasses all fall under Class I medical devices.
清关必备文件/Customs Clearance Documents:
需要同时具备：
1. FDA注册号
2. FDA滴珠测试证明（21 CFR 801.410冲击测试）
3. 出厂批次质量检验合格文件
Required documents:
1. FDA registration number
2. FDA drop ball test certificate (21 CFR 801.410 Impact Test)
3. Batch quality inspection certificate
一、落球测试（耐冲击测试）要求/Section 1: Drop Ball Test Requirements
测试方法：将钢球从规定高度落在镜片凸面，观察是否破碎。FDA主要测试镜片抗冲击性，测试时会用夹具固定镜架。
Test method: A steel ball is dropped from specified height onto the convex surface of lens to observe breakage. FDA primarily tests lens impact resistance using frame fixtures during testing.
二、FDA认证办理流程/Section 2: FDA Certification Process
1. 提交申请/Application Submission
需提交：产品说明、生产计划、测试计划、标签和包装设计等材料
Required documents: Product description, production plan, test plan, labeling and packaging design, etc.
2. 性能测试/Performance Testing
样品送至认证实验室检测，不合格需整改直至通过
Samples sent to certified labs, failures require correction until passing
3. 报告审核/Report Review
认证实验室提交测试报告，FDA审核产品规格、测试结果等
Certification lab submits test reports, FDA reviews product specifications and test results
4. 颁发证书/Certification Issuance
证书包含产品信息、认证结论和有效期
Certificate includes product information, certification conclusion and validity period
认证价值/Certification Value:
1. 保障消费者安全使用
2. 提升产品质量和信誉度
3. 增强国际市场竞争力
Benefits:
1. Ensures consumer safety
2. Improves product quality and credibility
3. Enhances international market competitiveness
