FDA Pre-Submission
$4,000
Typical consulting fee
Preparation of the PreSTAR meeting request, meeting preparation, attendance and meeting minutes.
Not included: Testing protocols and FDA fees.
See what the service covers →Pricing
Our prices are not a secret.
Regulatory consulting can be expensive, and many firms will not discuss fees until after a sales call. We prefer to be clear from the start. Below are the prices we typically charge for common FDA projects.
All prices are in US dollars.
You receive a written scope and estimate before work begins.
Submission services
These prices cover our consulting work for a standard, single-device project.
FDA 510(k) Submission
$18,000
Typical consulting fee
Preparation of a standard, single-device eSTAR submission and support with FDA Additional Information requests.
Not included: FDA user fees, testing, clinical studies and extensive remediation.
See what the service covers →FDA De Novo Submission
$23,000
Typical consulting fee
Preparation of a standard De Novo submission, including classification rationale and benefit-risk documentation.
Not included: FDA user fees, testing, clinical studies and extensive remediation.
See what the service covers →Other FDA services
Breakthrough Device Designation
Includes one revision and resubmission if the first request is denied.
$3,000
513(g) request — 510(k) pathway
For a focused classification request without additional De Novo documents.
$1,500
513(g) request — De Novo pathway
For a classification request with additional De Novo documentation.
$4,500
Regulatory pathway, predicate and testing plan
A written pathway recommendation, predicate shortlist and testing-plan review.
$1,500
US Agent — initial registration
US Agent service with initial FDA establishment-registration support.
$800
US Agent — annual renewal
Annual US Agent and registration-renewal support.
$600
Hourly rates
We use hourly billing when the work is open-ended or too small for a project fee.
Principal consultant$450/hour
Senior regulatory consultant$375/hour
Regulatory consultant$300/hour
Regulatory project support$225/hour
Work that needs a custom quote
Usability engineering, document remediation and rescue projects depend heavily on the quality of the existing work. We review the records first and give you a written estimate. There is no charge for work you have not approved.
Ask for an estimate →Questions about pricing
Are these fixed prices?+
These are our typical fees for a standard scope. We review your device first and give you a written estimate before starting. If the scope needs to change, we discuss it with you before doing additional work.
Why do some 510(k) quotes reach six figures?+
Some quotes combine consulting, laboratory testing, clinical work, cybersecurity remediation, software documentation and FDA fees. We show our consulting fee separately so you can compare like with like.
What is not included?+
FDA fees, laboratory testing, clinical studies, standards purchases, travel and other third-party costs are not included unless they appear in your written proposal.
Not sure which service you need?
Send us a short description of your device. We will tell you where we think you should start.