510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
US FDA De Novo classification request
There is no predicate for my device. What route is left?
- AuthorityUS FDA
- JurisdictionUnited States
- Type Market-access route
- Our scopeCoordinated by Prequel
What this route requires
De Novo is the route for novel devices of low to moderate risk where no suitable predicate exists, so a 510(k) has nowhere to anchor.
The bar is higher than a 510(k) in a specific way. A successful De Novo creates a new device classification, along with the special controls that will govern it — so the submission has to establish what those controls should be, rather than compare against controls somebody else already established. You are writing the rule, not following it.
That has an upside worth planning for: once granted, the classification becomes a predicate that competitors can use. Being first through carries both the cost and the position.
Applies to
Novel low-to-moderate-risk devices with no suitable predicate available.
Our scope
How Prequel supports it
- Assess whether De Novo is genuinely the right route rather than 510(k) or PMA
- Characterise the risks and benefits the request has to address
- Define the evidence strategy and propose the special controls
- Assemble the submission package
- Run the submission with a US regulatory specialist and manage FDA questions
Coordinated by Prequel. We build the pathway assessment, the evidence strategy and the submission package. The filing is run with a US regulatory specialist under our scope and review — FDA submission experience sits with that partner, not in house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
PMA — US FDA
My device is high risk. What does a PMA actually demand?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Not sure De Novo — US FDA is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.