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Starter

Essential compliance services

Label Compliance Review$299/SKU
Listing Audit (Amazon/TikTok)$199/listing
Prior Notice Filing$49
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Enterprise

Advanced & ongoing services

510(k) Submission Support$5,000+
NDI / GRAS Filing$3,000+
Monthly Retainer$2,000–5,000/mo
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Note on FDA Government Fees: FDA charges its own fees directly — these are not included in KECC service fees. Annual establishment registration: $11,423/yr. 510(k) review fee: $26,067 (standard) or $6,517 (small business). These fees are paid directly to FDA by the client.
FDA Regulatory Experts · Irvine, CA · keccfda.com
Advisor

Amy Chen

FDA Regulatory Advisor · KECC

Hi! I'm Amy, KECC's FDA compliance advisor. 👋

Ask me anything about FDA US Agent, MoCRA, label review, or 510(k).

你好!有任何 FDA 合规问题都可以问我 😊