510(k) Gap Assessment
A gap assessment is a written comparison between what your device already has and what a 510(k) submission requires.
It names each missing item, the cost of obtaining it, and the lead time.
The assessment supports two decisions: whether to file, and what to budget.
The assessment is free. It exists because a fixed price for the build is only honest once someone has read your actual documents.
At a glance
| What it is | A written assessment of your device against 510(k) requirements. |
|---|---|
| Who it is for | Companies that intend to file but do not yet know the size of the job. |
| What you receive | A report naming every gap, the cost to close it, and a recommended predicate. |
| Turnaround | Returned before the build scope is set. |
| Fee | No charge. |
| What it decides | Where your 510(k) build sits in the $11,000 to $20,000 range. |
| What it is not | It is not a submission, and it is not a guarantee of clearance. It is a decision document. |
What the report contains
- Your product code and device class, confirmed against FDA's classification database.
- Whether a 510(k) is required, exempt, or whether another pathway applies.
- A recommended predicate device, with the K-number and the reasoning for choosing it.
- Every test report you already hold, assessed against the standards FDA recognizes.
- Every test you do not yet hold, with typical laboratory cost and lead time.
- The FDA fee that will apply to you, including whether you qualify for the small business rate.
- A realistic timeline from today to a submission, and from submission to a decision. The second figure is calculated from FDA's records for manufacturers in your country. It is not an estimate.
- The name of the former FDA reviewer who checked the assessment before it was sent to you.
How the predicate recommendation is made
Every 510(k) decision FDA has ever issued sits in our database, over 175,000 of them, alongside 4,735 clearance letters read line by line.
That means the predicate we recommend is one FDA has already accepted for a device like yours, in your category, in recent years. You receive the K-numbers and can check every one of them in FDA's public database before you decide anything.
Where another route suits your device better than a 510(k), the report says which one and why. Knowing that at the start is worth considerably more than discovering it later.
What we examine
You send us what you have. We work from the documents themselves, not from a summary on a form, because the gaps are usually inside the documents.
- Device description, drawings, photographs and specifications.
- Existing test reports, including any prepared for CE marking or a domestic submission.
- Your current labeling and instructions for use.
- Any predicate you have already identified, if you have one.
- Quality system documentation, to the extent it affects the submission.
Why the assessment comes first
A fixed price is only honest once someone has read your actual documents. The assessment is what makes it possible to quote your build to the dollar before you commit to anything.
It also settles the two decisions that shape every submission.
All three are visible in your documents long before a submission is written. Finding them is what the assessment does, and settling them is what lets everything after it run to a fixed price and a known scope.
What happens after
You own the report. You may use it to file the submission yourself, to brief another consultant, or as the basis for deciding not to proceed at all.
Where a requirement is not yet met, the report names it and sets out exactly what closes it. Companies routinely complete that work in about three months and file on schedule.
Questions people ask
How is this different from the free device check?
The free check returns your product code, class, whether a 510(k) is required, and three cleared devices in the category. The gap assessment examines your actual documents and tells you what closing the difference costs. The free check answers “do I need one”. This answers “what will it take”.
Can we use the report with another consultant?
Yes. It is your document and it is written to be used by anyone.
What if we already have a predicate in mind?
We assess it. Confirming a predicate that works is as useful a result as replacing one that does not, and it takes the same effort to check.
Do you need our quality system documents?
Only to the extent they affect the submission. A full quality system audit is separate work.