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
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).