FDA Medical Device Establishment Registration and Listing Fees
Transparent, competitive fees for all FDA registration, compliance, and U.S. Agent services. No hidden charges. Price-locked since 2009.
Price-Lock Since 2009
No Hidden Fees
150+ Countries Served
Since 2009
Medical Device Establishment
21 CFR Part 807 — Annual Registration Required
| FDA Registration & U.S. Agent Service | USD 449 / Year · + Govt MDUFA fee: $11,423 | |
| Device Listing | USD 50 / Device · No govt fee | |
| GUDID Account Creation Assistance | USD 349 No govt fee | |
| Medical Device Label Review | USD 649 / Device | |
| UDI Device Listing | Contact Us | |
| FDA 510(k) Premarket Submission | Contact Us | |
About Government Fees: The fees listed above are LMG professional service fees only. Some services include separate government fees charged directly by FDA — for example, the MDUFA device registration fee (FY2027: $13,785) and the export certificate filing fee ($175). These are paid to the U.S. government and are not retained by LMG. Government fees are noted above where applicable. All LMG fees are unchanged since 2009.
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