Why RegTrackr?

As a regulatory affairs professional, I used to spend hours every month tracking down updates, scanning government websites, and compiling information from multiple sources — just to stay informed. It was time-consuming, repetitive, and a major distraction from the real work.

I started asking myself: how could I automate this critical but tedious part of the job?

That’s how RegTrackr was born — a tool designed to centralize key regulatory information and reduce time wasted on manual monitoring.

RegTrackr brings together regulatory news, vigilance case reports, and cybersecurity alerts from various trusted sources.

For U.S. market monitoring and vigilance (adverse events and recalls), RegTrackr connects directly to the FDA’s public APIs. While the data remains the same, RegTrackr displays more relevant information up front, making it easier to scan, compare, and interpret results without needing to open each individual entry.

Built by someone who’s experienced these challenges firsthand, RegTrackr helps you shift your focus — from endlessly searching for updates to actually analyzing what matters.

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Understand Intended Use & Determine Classification

As regulatory professionals, one of the first questions we often face is: “Is this product even a medical device?” Determining that can be time-consuming and complex, especially when the intended use isn't straightforward.

RegTrackr offers a simple tool to help guide that early assessment. Based on the product’s intended use, it provides an initial indication of whether it may qualify as a medical device or an in vitro diagnostic. While not legally binding, this feature helps structure your reasoning and support internal decisions.

For products identified as devices, RegTrackr includes a dedicated classification module. Through a step-by-step Q&A logic, the tool determines the applicable class in Europe and Australia, and automatically generates a summary report for documentation.

In the U.S., where classification relies on pre-defined product codes, RegTrackr goes further by checking your product’s intended use against the entire FDA product code database — helping you identify the closest matching codes and relevant regulatory pathways.