Product Classification & Regulatory Pathway Assessment

Before testing begins or a dossier is drafted, we establish the device's regulatory identity: classification, regulation number, product code, applicable controls, exemption status and likely premarket pathway. This early assessment prevents costly work from being built around the wrong FDA route.

Request a Regulatory Pathway Assessment

What This Service Is

FDA classification determines the regulatory framework that applies to a device. It influences whether premarket notification (510(k)), De Novo classification, PMA or another pathway may be required, and it shapes the applicable controls, evidence expectations and submission strategy.

NKB Regovanta approaches classification as the first regulatory decision in the program — not as an administrative database search.

When It Is Needed

For a new Medical Device or IVD entering the US market

When the product code or classification is uncertain

When the device combines functions or technologies that do not fit neatly into an existing category

When an existing product is being modified or repositioned for a new intended use

Before predicate research, testing or submission planning begins

How We Assess the Pathway

We review intended use, indications, technological characteristics, mode of action, patient population, risk, comparable legally marketed devices and FDA classification history. The output is a reasoned pathway recommendation that can be used to drive predicate research, testing and submission planning:

Device class, regulation number and product code

Applicable exemption status (GMP / 510(k) exempt)

Likely submission pathway (510(k), De Novo, PMA, 513(g))

Regulatory controls and key evidence expectations

Areas of uncertainty that may warrant FDA interaction (Q-Sub)

Our Difference

Defensible Strategy Tied Directly to Your Claims

We do not stop at assigning a product code. We ask whether the classification logic remains defensible when connected to the intended use, technology, claims and evidence strategy that will appear later in the FDA submission.

FDA Classification Highlights

Class I: Low Risk (Majority 510(k) Exempt)
Class II: Moderate Risk (510(k) Premarket Notification / De Novo)
Class III: High Risk (Premarket Approval - PMA)

Need Classification Clarity?

Avoid costly missteps by securing a robust regulatory identity for your device early.

Request Pathway Assessment

Ready to Establish Your FDA Regulatory Identity?

Connect with our US FDA regulatory strategy team for an authoritative classification and pathway roadmap.

Book a Consultation