510(k) vs. De Novo: Key Differences in FDA Approval Pathways for Medical Devices

510(k) vs. De Novo: Key Differences in FDA Approval Pathways for Medical Devices

Medical device manufacturers entering the U.S. market must carefully evaluate the FDA regulatory pathways available to them. For most non–PMA (Premarket Approval) devices, two primary options exist: the 510(k) Premarket Notification and the De Novo Classification Request. While both routes enable market access, the criteria, timelines, and long-term impact differ significantly.

Here’s a closer look at the key differences between 510(k) vs. De Novo pathways and what manufacturers should consider before submission.

The 510(k) Pathway Explained

The 510(k) submission process is designed for devices that can be demonstrated as substantially equivalent to a device already legally marketed in the U.S. (the predicate).

To qualify, a device must:

• Share the same intended use as the predicate device.

• Contain similar technological characteristics, or prove that any differences do not introduce new safety or effectiveness concerns.

When the FDA confirms substantial equivalence, it issues a Substantially Equivalent (SE) Letter, which grants clearance to market the device in the U.S.

Average review time: about 90 calendar days.

This makes 510(k) the preferred pathway for manufacturers seeking a faster, cost-effective approval process when comparable devices already exist.

The De Novo Pathway Explained

The De Novo process applies to novel devices that have no suitable predicate but still pose low to moderate risk. These products are not eligible for 510(k) clearance but do not require the stringent PMA route either.

Upon successful review, the FDA issues a De Novo Grant Order that:

• Formally authorizes the device for U.S. marketing.

• Establishes a new device classification under 21 CFR.

• Assigns a product code and defines any special controls needed for safe use.

This pathway not only permits market entry but also creates a new regulatory category, setting standards for future devices of the same type.

Comparing 510(k) vs. De Novo Pathways

The main distinction between the two pathways is the presence (or absence) of a predicate device.

Manufacturers can pursue De Novo in two ways:

1. Post-NSE De Novo: After an unsuccessful 510(k), when FDA rules the device Not Substantially Equivalent (NSE).

2. Direct De Novo: When it’s clear no predicate exists, the sponsor submits directly.

While 510(k) offers speed, the De Novo route provides strategic benefits, particularly for first-of-its-kind or AI-driven technologies, by setting a precedent for the market.

Post-Market Responsibilities

Approval or clearance is only the first step. Both 510(k) and De Novo devices must comply with FDA post-market requirements, including:

• Quality System Regulation (21 CFR Part 820): Covering design controls, manufacturing practices, and quality assurance.

• Medical Device Reporting (21 CFR Part 803): Monitoring and reporting adverse events.

• Unique Device Identification (UDI) Compliance: Labeling and submission to the FDA’s GUDID database.

• Special Controls (De Novo only): Device-specific requirements that must be maintained.

Failure to meet these obligations can lead to FDA enforcement actions, recalls, or suspension of marketing authorization.

Choosing Between 510(k) and De Novo

The choice between 510(k) vs. De Novo FDA pathways depends on three critical factors:

• Does a valid predicate device exist?

• What is the device’s risk classification?

• What are the company’s long-term strategic goals?

Selecting the right pathway from the outset accelerates FDA approval, ensures compliance, and strengthens market competitiveness.

Conclusion

The decision between 510(k) vs. De Novo is more than just a regulatory formality—it directly influences market entry speed, compliance obligations, and long-term positioning.

• 510(k): The faster, cost-effective option when a predicate exists.

• De Novo: The ideal choice for novel, low to moderate risk devices that require a new classification.

To explore a detailed breakdown of these pathways, visit the full blog on Freyr Solutions: 510(k) vs. De Novo – Key Differences in FDA Approval Pathways for Medical Devices.

At Freyr Solutions, we specialize in helping medical device manufacturers navigate FDA submissions with confidence. From regulatory strategy to dossier preparation and post-market compliance, our experts ensure faster approvals and smoother market entry.

👉 Contact us today to identify the right FDA approval pathway for your device.