What establishment registration fee does FDA charge?

For fiscal year 2027, October 1, 2026 to September 30, 2027, the annual fee is $13,785; fiscal 2026 was $11,423. Device establishments must register every year, and most must pay the fee.

Should I scale overhead by device risk class?

Not with a guessed multiplier, because it makes standard cost recover more or less than you actually spend. If a higher-class line takes more effort, charge its own filings, studies and dedicated staff to it directly.

Does a 510(k) user fee belong in yearly regulatory overhead?

Yes, when you spread filings across all products. FDA's fiscal 2027 standard 510(k) fee is $28,653, or $7,163 for a qualified small business; add the test reports and consultant time behind the filing.

Why divide by released devices rather than devices built?

Because released devices are what you sell and what carries standard cost. Dividing by devices built spreads overhead over units later scrapped, so the released product under-recovers it.

MedTech Manufacturing calculator

Regulatory Overhead per Unit Calculator

Find how much quality and regulatory overhead each released device must carry before you set standard cost or price a low-volume line. You need the year's payroll, fees, registration and filing costs, released devices and your allowance.

What this calculator does

Quality and regulatory overhead per released device, built from payroll, audits, FDA registration and filings, against the allowance in standard cost.

Formula used

Regulatory overhead per year = payroll + audit, certificate and software fees + establishment registration fee + submissions cost
Regulatory overhead per device = overhead per year ÷ released devices per year
Each component per device = that cost per year ÷ released devices per year
Release volume needed for allowance = overhead per year ÷ regulatory allowance per device, rounded up

Inputs explained

Quality and Regulatory Payroll per Year: Loaded pay of quality and regulatory staff, from the budget.
Audit, Certificate and Software Fees per Year: Registrar or notified body audits, certificates and quality system software.
Establishment Registration Fee: FDA fiscal 2027 fee of $13,785 per registered establishment, times your establishments.
Submissions Cost per Year: User fees, test reports and consultants for this year's premarket filings.
Released Devices per Year: Devices released for distribution in the same year, from the release log.
Regulatory Allowance per Device: Quality and regulatory overhead per device in your standard cost.

How to use the result

Best suited to loading regulatory overhead into standard cost, pricing a low-volume specialty device, budgeting a year with premarket filings.
Excludes event costs such as complaint investigations, corrective actions and recalls; price those separately. A product with its own filings or clinical studies should carry those directly, not through this average.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

What establishment registration fee does FDA charge? For fiscal year 2027, October 1, 2026 to September 30, 2027, the annual fee is $13,785; fiscal 2026 was $11,423. Device establishments must register every year, and most must pay the fee.
Should I scale overhead by device risk class? Not with a guessed multiplier, because it makes standard cost recover more or less than you actually spend. If a higher-class line takes more effort, charge its own filings, studies and dedicated staff to it directly.
Does a 510(k) user fee belong in yearly regulatory overhead? Yes, when you spread filings across all products. FDA's fiscal 2027 standard 510(k) fee is $28,653, or $7,163 for a qualified small business; add the test reports and consultant time behind the filing.
Why divide by released devices rather than devices built? Because released devices are what you sell and what carries standard cost. Dividing by devices built spreads overhead over units later scrapped, so the released product under-recovers it.

Last reviewed 2026-10-01.