性价比最高的深圳SEO推广公司 | 眼镜FDA认证常见问题解答
为什么谷歌推广效果不精准？
Why is Google Ads not precise?
眼镜作为FDA强制管控的医疗产品，出口美国必须完成FDA注册。以下是常见问题解答：
As FDA-regulated medical devices, eyewear must be FDA registered for US export. Here are FAQs:
1. 买方提供FDA认证后，卖方是否仍需提供？
1. If buyer provides FDA certification, does seller still need to?
必须提供。根据法规807.40(a)，制造商必须自行完成注册并承担费用。
Yes. Per regulation 807.40(a), manufacturers must complete registration themselves and bear the cost.
2. 不同类型眼镜能否共用FDA认证？
2. Can different eyewear types share one FDA certification?
可以。FDA注册包含企业注册和产品列名，同一企业可将所有产品列在同一注册号下。
Yes. FDA registration includes establishment registration and product listing. One registration can cover all products.
3. FDA认证费用和周期
3. FDA certification cost and timeline
2021年规费5546美元（510K豁免类）。注册免费但需专业指导，完整流程约1-2周注册+3个月审核。
2021 fee $5546 (510K exempt). Registration is free but needs guidance. Process takes 1-2 weeks registration + 3 months review.
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Contact us for professional FDA registration!
