Most FDA regulatory consulting firms answer this question with "schedule a call." ADB Consulting & CRO Inc. publishes flat fees on the website, so this post can answer with actual numbers: what each service costs, what is included, and what sits outside the consulting fee entirely. All prices below are the same figures published on our service pages.
Why We Publish Pricing When Almost No One Else Does
Ambiguous pricing works in a consultant's favor — every engagement becomes a negotiation, and the quote flexes based on how big the client looks. We publish flat fees for three reasons. First, budget planning: a founder preparing a first 510(k) submission cannot build a fundraising model around "it depends." Second, accountability: when the price is public, the scope has to be defined before the engagement starts, not discovered invoice by invoice. A flat fee places the efficiency risk on the consultant; hourly billing places it on the client. Third, it makes the free discovery call about your device and pathway rather than a pricing dance.
510(k) Submission Consulting — From $4,950 to $24,500+
A 510(k) gap assessment is $4,950: a structured review of your existing documentation against FDA's Refuse to Accept checklist and substantive review expectations, identifying what you have, what is missing, and what testing is likely required. The Pre-Sub tier within a 510(k) engagement is $4,500. Full-service 510(k) preparation starts at $24,500 and covers predicate analysis and selection rationale, the substantial equivalence comparison, testing strategy, assembly of all submission sections, eSTAR formatting, quality review, and FDA response management through the review cycle. Full-service work is scoped in writing and milestone-billed by invoice; the fixed-scope assessments are paid online.
FDA Pre-Submission Consulting — $6,500
The standalone Pre-Sub package is $6,500 and includes development of the regulatory questions worth asking FDA, the briefing document, proposed testing framing, submission through the appropriate channel, and preparation for FDA's feedback. FDA does not charge a user fee for Pre-Submissions, so the consulting fee is effectively the entire budget line. For devices with a clear predicate and well-worn testing standards a Pre-Sub may be unnecessary; for AI/ML SaMD, novel technology, or borderline classifications it can reduce the risk of a costly deficiency cycle.
QMS Gap Assessment — $3,495 and $6,995
Stage 1 ($3,495) is a documentation-level review of your procedures against QMSR (21 CFR Part 820 as amended) and ISO 13485:2016. Stage 2 ($6,995) reviews implementation evidence — whether records demonstrate the procedures are actually followed. Together they mirror how a certification body or an FDA investigator approaches a quality system. The deliverable is a findings report with a prioritized remediation path; remediation is scoped separately, so you are never buying fixes for problems that have not been verified. Full details on our QMS gap assessment service page.
FDA Cybersecurity (Section 524B) Gap Assessment — $3,495
Section 524B applies to cyber devices — devices that include software, can connect to the internet, and could be vulnerable to cybersecurity threats. The $3,495 assessment reviews SBOM completeness, threat modeling, security risk assessment, vulnerability management planning, and premarket documentation readiness. FDA can refuse to accept a submission for a cyber device that lacks this documentation, and cybersecurity deficiencies have become a common reason connected-device submissions stall. See our 524B cybersecurity gap assessment page for full scope details.
513(g) Device Classification — $1,495 or $2,995
Two options. A classification memo ($1,495) is our professional analysis of your device's classification, regulation number, product code, and likely pathway — sufficient for most planning and investor purposes. A formal 513(g) Request for Information ($2,995 plus FDA's 513(g) user fee at the current fiscal-year rate) puts the question to FDA and returns FDA's official written answer — appropriate when the classification is genuinely ambiguous and you need FDA's position on the record.
What the Consulting Fee Does Not Include
Two budget lines sit outside any consultant's fee. FDA user fees are paid directly to FDA at the current fiscal-year rate, with reduced rates for qualified small businesses — current amounts are listed on our device registration page. Third-party testing (biocompatibility, electrical safety and EMC, sterilization validation, bench performance) is highly device-dependent and frequently represents the largest share of total project cost for complex devices. Part of the consulting work is designing a testing strategy that avoids paying for tests FDA does not require.
How a Startup Should Sequence Spending
A rational sequence converts unknowns into defined budgets before the large commitment: classification memo ($1,495) to confirm the pathway, then the applicable gap assessment ($3,495–$4,950) to size the real work, then a Pre-Sub if the pathway or testing plan warrants FDA's input ($4,500–$6,500), then the full submission (from $24,500). Each step de-risks the next, and none requires committing to the full engagement up front.
Frequently Asked Questions
How much does 510(k) consulting cost?
ADB publishes flat fees: a 510(k) gap assessment is $4,950, the Pre-Sub tier is $4,500, and full-service 510(k) preparation starts at $24,500, with scope defined in writing before the engagement starts.
How much does an FDA Pre-Submission cost?
ADB's Pre-Sub package is a flat $6,500. FDA does not charge a user fee for Pre-Submissions.
How much does a QMS gap assessment cost?
Stage 1 is $3,495 (documentation-level review against QMSR and ISO 13485:2016); Stage 2 is $6,995 (implementation evidence review). Both are flat fees with defined deliverables.
How much does FDA cybersecurity (Section 524B) consulting cost?
ADB's 524B gap assessment is a flat $3,495, covering SBOM, threat modeling, security risk assessment, and premarket documentation readiness.
How much does it cost to determine my device's FDA classification?
A classification memo is $1,495. A formal 513(g) Request for Information is $2,995 plus FDA's 513(g) user fee at the current fiscal-year rate.
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