Software for an FDA De Novo submission: what actually helps in 2026

If your device is genuinely novel, low to moderate risk, and has no legally marketed predicate to point at, the De Novo classification request is your route to market. It is the FDA saying "this is new, so we will create a classification for it." That is exciting and a little daunting at the same time, because there is no existing device to copy your submission from.

The good news: the documentation a De Novo expects is structured and knowable. The work is in producing it cleanly and being able to show your reasoning. That is exactly where the right software earns its place.

De Novo vs 510(k): why the distinction matters

The two pathways pull on your records differently, so it is worth being clear which one you are on. A 510(k) relies on demonstrating substantial equivalence to a predicate device. A De Novo has no predicate, so instead of "we are like this approved thing," you are building a risk-based case from first principles: here is the device, here is what could go wrong, here are the controls that bring that risk down to acceptable.

If you are weighing both routes, our guide to the best QMS for an FDA submission covers the 510(k) side in more detail. This page is specifically about the De Novo case, where the absence of a predicate puts more weight on your risk file and your evidence.

What a De Novo submission actually leans on

Across a De Novo, the same core records do the heavy lifting:

• A clear description of the device and its intended use
• Software requirements, documented and versioned
• Verifications linked to those requirements
• Test evidence (test runs) attached to each verification
• A traceability matrix tying it all together
• A risk analysis under ISO 14971, with controls and residual risk
• Structured change and approval records
• Your general and special controls rationale

Because there is no predicate, the FDA reviewer is reading your risk reasoning closely. The strength of your submission is the strength of your traceability and your risk file. Software that keeps those connected, and current, is what turns a De Novo from a document-archaeology project into a process.

What software actually helps

| Tool | Best for | Pricing | |---|---|---| | Greenlight Guru | Hardware device companies running a full submission | ~$1,000+/month | | Qualio | Teams with a dedicated quality manager | ~$500-800+/month | | Codebeamer (PTC) | Large multi-discipline engineering teams | Enterprise | | QualiHQ | Software and SaMD teams assembling their own evidence | Free tier available |

Greenlight Guru

Built for hardware medical device companies and strong on design history file structure and submission workflows. If you are a hardware team running a De Novo with a regulatory function in place, it is a serious option. For a pure software team it carries features you will not use, at a price that assumes you are past the startup stage.

Qualio

Solid life sciences document control, CAPA, and training management, built for teams that already have a quality manager to run it. A reasonable fit once you have grown into a dedicated quality function, less so when a founder or CTO is assembling the submission themselves.

Codebeamer (PTC)

Application Lifecycle Management for large engineering organisations. Powerful and comprehensive, but the implementation overhead is hard to justify for a startup preparing a single De Novo.

QualiHQ

Built for software and SaMD teams who are assembling their own evidence. Requirements, verifications, and traceability are generated from your existing documentation and kept linked as you work, and your test runs import automatically. The risk analysis lives in the same system as the requirements it controls, so the risk reasoning a De Novo reviewer wants to see is connected to the evidence rather than maintained in a separate spreadsheet. Free to start, no credit card.

Best for: SaMD and digital health teams building a novel product and preparing a De Novo without a large regulatory team.

The recommendation

A De Novo is won on clear reasoning and complete traceability, not on volume of paperwork. Start with a system that keeps your requirements, test evidence, and risk file connected from day one, so that when you assemble the submission, you are exporting a story that already holds together rather than reconstructing one. Knowing your IEC 62304 software safety class first also tells you how heavy the evidence burden will be, and our free classifier gives you that in two minutes. Its device-class output is oriented to EU MDR rather than the FDA, but the IEC 62304 software safety class and the QMS foundation it points to apply to a De Novo just the same.

Frequently asked questions

What is an FDA De Novo submission?

A De Novo classification request is the FDA pathway for a novel device that is low to moderate risk but has no legally marketed predicate device to support a 510(k). Rather than demonstrating substantial equivalence, you make a risk-based case for the device and propose the general and special controls that make it safe and effective. If granted, the FDA creates a new device classification, and your device can then serve as a predicate for others.

How is a De Novo different from a 510(k)?

A 510(k) demonstrates that your device is substantially equivalent to an existing, legally marketed predicate. A De Novo is used when no suitable predicate exists, so the burden shifts from comparison to a standalone risk and controls argument. In practice a De Novo puts more weight on your risk analysis and traceability, because the reviewer cannot lean on an approved comparator.

Do I need a QMS for a De Novo submission?

Yes. A functioning quality management system aligned with FDA 21 CFR Part 820 (and IEC 62304 for software) is expected, and the records it produces, requirements, verifications, test evidence, risk analysis, and change control, are the substance of the submission. Building that QMS early means your De Novo is an export of existing records rather than a scramble to create them.

Can a small team prepare a De Novo without a regulatory consultant?

You can build the documentation foundation yourself, and you should, because it makes any consultant engagement far shorter and cheaper. A specialist is most valuable for confirming your classification and reviewing the final submission, not for building your day-to-day records. Arriving with your QMS, risk file, and traceability already in place is what keeps that engagement focused and affordable.

QualiHQ is free to start. No credit card required. Generate your first requirements and risk file from your existing documentation in minutes.