FDA Regulatory Strategy
A regulatory strategy is a written document that establishes your route to market clearance.
It sets the classification of your device, the pathway it must take, the predicates that support it, and the claims you can make.
Prepared by a regulatory affairs professional with 10 to 25 years of direct 510(k) experience.
- Deliverable
- Written regulatory strategy
- Fee
- $3,000, fixed
- Prepared by
- 10–25 years of 510(k) experience
- Covers
- Class, pathway, predicates, claims
- You own it
- Use it with anyone
- Next step
- Defined scope and cost
Four decisions determine everything that follows.
Four questions decide the shape, cost and timeline of an FDA submission. The strategy answers all four in writing.
Classification
Which class your device falls in, and under which product code.
Class I, II or IIIProduct codePathway
Class I registration, a 510(k), or another route entirely.
Registration510(k)Predicates
Which cleared devices support your submission, identified by K-number and analyzed against your device.
K-numberAnalyzedClaims
Which indications you can support with the evidence you have, and which you cannot.
SupportedEvidence needed
Answering these before any build work begins is what makes a fixed price possible. It is also what settles the two things that matter most: a predicate that qualifies, and claims the evidence actually supports.
Every quotation you receive is a guess.
In our experience, most companies arrive knowing they want FDA clearance and not knowing what that requires. The class is uncertain, the pathway is uncertain, and every quotation they receive is therefore a guess.
The strategy removes the uncertainty first. From that point the route is defined, the cost is fixed, and each step is chosen rather than discovered.
| Decision | Before | After |
|---|---|---|
| Classification | Uncertain | Confirmed |
| Pathway | Uncertain | Defined |
| Predicates | Unidentified | Analyzed |
| Claims | Unassessed | Assessed |
| Project cost | A guess | Fixed |
A decision document, not a slide deck.
The document is yours. You can build the submission with us, build it yourself, or take it to another firm.
Product code and device class
Confirmed against FDA classification.
Regulatory pathway
The pathway your device must take, with the regulatory basis for that conclusion.
Predicate analysis
Predicate devices identified by K-number, with the analysis supporting each.
Claim assessment
An assessment of the claims you intend to make against the evidence available.
Build scope
The scope and cost of what follows, so the next decision is made with figures in front of you.
Sometimes the best submission is no submission at all.
If your device turns out to be Class I and exempt, the strategy tells you that, and your path is a registration rather than a submission.
Start with a Regulatory Strategy. Everything else depends on it.
- $3,000
- Fixed fee
- Written deliverable
- Yours to keep
Which pathway is right for your device?
| Pathway | Device class | Complizen timeline | FDA user fee | When to use |
|---|---|---|---|---|
| Traditional 510(k)Most common | Class II | 2–4 months | $28,653 | Substantially equivalent to a cleared predicate |
| Special 510(k) | Class II | 2–3 months | $28,653 | Design changes to your own cleared device |
| De Novo | Class II (novel) | 6–12 months | $191,020 | Novel device with no cleared predicate — creates a new product code |
| PMA | Class III | 1–2 years | $636,732 | High-risk device — life-sustaining or implanted |
| Exempt | Class I / some II | 5 days | $0* | Low-risk device meeting specific exemption criteria |
FDA user fees are the rates from 1 October 2026; small businesses pay $7,163 for a 510(k), $47,755 for a De Novo, and $159,183 for a PMA. Timelines are Complizen estimates and vary by device and evidence.
*Exempt applies to the submission fee only. An exempt manufacturer still owes establishment registration, $13,785 per year from 1 October 2026.
At a glance
| What it is | A written strategy establishing your classification, pathway, predicates and claims. |
|---|---|
| Who it is for | Every device that will be regulated by FDA. This is the shared first step. |
| What it settles | Whether your device is Class I and registers, or Class II and requires a 510(k). |
| What you receive | A written strategy document, yours to keep and to use with anyone. |
| Fee | $3,000, fixed. |
| What it unlocks | For a 510(k), completing the strategy opens your task list on the platform and defines the build. |
| Who prepares it | A regulatory affairs professional with 10 to 25 years of direct 510(k) experience. |
Questions people ask
Do we need this if we already know our product code?
If your code and class are settled and a comparable device is already cleared under it, the strategy will confirm that quickly. Many companies are less certain than they think, and the confirmation is what the fixed build price rests on.
What if the strategy concludes our device is Class I?
Then your route is registration and listing rather than a submission, at a fraction of the cost.
Can we use the strategy with another consultant?
Yes. It is your document and it is written to be used by anyone.
Will you recommend a pre-submission meeting with FDA?
Where the pathway question is genuinely open, yes. A pre-submission is often the cheapest way to settle a disagreement about pathway before it becomes an expensive one.
Our previous submission was found not substantially equivalent. Can you tell us why?
Usually. FDA decision letters state the basis, and the underlying cause is normally the predicate or the evidence supporting the comparison. Send us the correspondence with your device details.
“The regulatory strategy review pointed us at the right pathway from day one — with citations. We knew we weren’t missing something critical, and that confidence is hard to put a price on.”
Prefer to do it yourself?
Complizen Starter
Build your regulatory strategy on the platform yourself — same AI, same Superagent, no expert session or 1-hour call.
- Same regulatory datasets
- Same AI infrastructure
- Superagent
- No expert review
- No strategy call
Regulatory Strategy
Or have us do it. A regulatory affairs professional with 10 to 25 years of direct 510(k) experience prepares the document, supported by Complizen AI.
- Written strategy document
- Predicate analysis
- Claim assessment
- Defined next-step scope and cost