510(k) Premarket Notification
The 510(k) is the most common premarket notification pathway for Class II medical devices. Before a submission can be assembled, a gap assessment identifies every missing or insufficient element — predicate device, substantial equivalence argument, and testing documentation — so you know exactly what remains to be prepared. All source inputs are provided by you; ADB prepares the review, the gap matrix, and the roadmap.
Published Pricing — Three Tiers
All three services begin with client-provided device information. ADB prepares the reviews, documentation, and submission package sections — we do not conduct testing or generate source data.
FDA 510(k) user fees are separate from ADB service fees and are paid directly to FDA. See current FDA fee schedule.
Scope of Service
ADB does not conduct testing or generate test data. All technical inputs are provided by you or your test laboratories. ADB’s role is to review those inputs, identify gaps, and prepare the submission package sections from the documentation you supply.
How It Works
Submit your device description, intended use, and any existing documentation. We review what you have and establish the starting baseline — no matter how early in development you are.
We identify the appropriate product code and propose a predicate device based on your intended use. We then review substantial equivalence gaps — intended use and technological characteristics — between your device and the proposed predicate.
We map your existing test documentation against applicable FDA guidance and FDA-recognized consensus standards, identifying each testing gap that must be addressed before the submission package can be assembled.
You receive a written submission roadmap listing every remaining documentation and testing item, followed by a debrief call to walk through the findings and agree on next steps. The roadmap is yours to keep regardless of whether you proceed with ADB for the submission itself.
Why Flat Fee
Hourly billing turns a straightforward gap assessment into an open-ended liability. The flat-fee structure means the scope is defined before work begins, the deliverables are specified in writing, and the cost is fixed. If the assessment surfaces complexity that changes the scope of a subsequent engagement, that is disclosed upfront — not billed retroactively.
The 100% credit toward Full Submission Package Preparation exists because a good gap assessment should make the subsequent submission faster, not duplicate work. If you proceed within 90 days, the gap assessment fee offsets directly against the quoted submission package price.
FDA User Fees
FDA charges a user fee for 510(k) submissions that is separate from any consulting or preparation fee. The fee amount is updated each fiscal year (October) and published in the Federal Register under the MDUFA program. Small businesses certified by FDA may be eligible for a reduced rate.
ADB does not collect or remit FDA user fees on your behalf for 510(k) submissions. The fee is paid directly to FDA at the time of submission. For current amounts, see the FDA MDUFA fee schedule or the device registration fee page for context on how annual MDUFA fees work.
Common Questions
No. ADB reviews the test documentation you or your test labs provide and identifies gaps against applicable FDA guidance and FDA-recognized consensus standards. All source test data, reports, and performance documentation are client-provided inputs. ADB does not arrange, supervise, or conduct testing.
The assessment delivers four written items: a product code and predicate device review; a substantial equivalence gap review against the proposed predicate; a testing-gap matrix mapped to applicable FDA guidance and FDA-recognized consensus standards; and a written submission roadmap identifying what remains before a 510(k) package can be assembled. The roadmap describes documentation gaps — it is not a clearance prediction.
Timeline is confirmed at kickoff based on device complexity and the maturity of existing documentation. The assessment is delivered on a defined schedule agreed at kickoff. A device with a clear predicate strategy and documented test plan requires less time than a device starting from scratch.
If you proceed with the Full 510(k) Submission Package Preparation service within 90 days of your gap assessment, the full $4,950 gap assessment fee is credited toward the quoted submission package price. The credit applies once, to one engagement, within the 90-day window.
A Pre-Submission (Q-Sub) is a formal FDA feedback mechanism where FDA reviews your submission strategy and provides written questions and answers before the submission is filed. It is not a prerequisite for the gap assessment. Some sponsors pursue both; others proceed directly to submission preparation. The right sequence depends on your device and predicate situation.
FDA charges an annual user fee for standard 510(k) submissions. The fee amount changes each fiscal year and is published in the Federal Register. Small businesses certified under FDA’s Small Business Certification program are eligible for a reduced rate. The current fee schedule is available directly on FDA’s MDUFA fee page — fees update each October. The FDA user fee is separate from ADB’s service fees and is paid directly to FDA.
Related Services
Unsure of your device class or pathway? A Classification Determination Memo or formal 513(g) Request obtains FDA’s written position before you begin the 510(k) process.
Not certain which pathway applies? Review the key differences between 510(k), PMA, and De Novo before committing to a submission strategy.
Clearance is one step — registration and listing with FDA is a separate annual requirement for all US device establishments.
Foreign manufacturers submitting a 510(k) must designate a US Agent with FDA before submitting. Flat-fee $595/yr.
A cleared device still requires a compliant quality system under 21 CFR Part 820 (QMSR). Flat-fee assessment with published pricing.
Get Started
Submit your details and we will confirm next steps within one business day. If you are requesting the Full Submission Package, include a brief device description and we will follow up to scope the engagement before quoting.
Sending your request…
Not Sure Where to Start?
If you are unsure whether the gap assessment, a Pre-Submission, or a different service is the right first step for your device, a scope call costs nothing and takes 30 minutes.