U.S.-based companies dominate the roughly $350 billion global medical device industry, and, as a result, the United States exports more medical devices than it imports.
The U.S. Food and Drug Administration (FDA) is responsible for regulating firms that manufacture, repackage, relabel, or import medical devices sold in the United States. It categorizes medical devices into three classes based on the level of regulatory control needed to provide reasonable assurance of safety and effectiveness. Because Class III devices pose a potential for serious risk to humans, all Class III devices must be evaluated in clinical trials before receiving Premarket Approval from the FDA.
The clearance process for Class I and II devices is often simpler and commonly does not require novel clinical trial data. Class I and II devices rely mostly on safety and performance data in accordance with quality regulations and consensus standards. Especially when clinical trials are not required, developing Class I and II devices is very feasible for small companies without large capital reserves.
However, although the process of FDA clearance for Class I and II medical devices is considered easier, the various submission standards are not always obvious or intuitive, and failure to properly navigate them can lead to wasted resources at best and federal prosecution at worst.
In this eBook, we review vital steps in receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process.
Download our eBook to learn more about:
- Understanding the classes and corresponding regulatory controls
- Confirming your device’s classification
- Identifying predicate devices already cleared for sale
- Defining your device’s Intended Use
- Developing a regulatory and strategic pathway
If you’re interested in more information about the regulatory path to market for low-risk medical devices, please click here to watch a recorded webcast and read our blog series where we addressed questions around clinical trial data, understanding classes, the application process, and mHealth.