When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make is choosing the correct regulatory pathway. For many manufacturers, that means understanding the FDA 510(k) process and how it compares to the Premarket Approval (PMA) route.
These two regulatory pathways represent the most common ways to gain FDA clearance or approval, but they differ significantly in requirements, risk classification, and timelines. Choosing the right one early on can help streamline your path to market and reduce costly delays. Keep reading to discover how 510(k) and PMA submissions compare, and which one might be the right fit for your medical device.
Why it matters: Choosing the right FDA submission path
Not all medical devices are created equal, and some carry more risk than others. The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories based on risk: Class I, II, and III. Most Class II devices require a 510(k) submission, while Class III devices generally need a PMA application.
Choosing the wrong path can cost you time, money, and delay your product’s launch. Missteps in your process can also result in rejections, warning letters, or costly remediation work. Understanding the differences between 510(k) and PMA submissions early on helps you plan your regulatory strategy with the FDA more effectively.
What is an FDA 510(k) submission?
A 510(k) submission is a type of premarket notification submitted to the FDA to demonstrate that a medical device is substantially equivalent to another legally marketed device, known as a predicate. This pathway is most commonly used for Class II medical devices.
Because it generally does not require clinical trials, the 510(k) process is often faster and more cost-effective than other pathways. According to the FDA, the typical review time for a 510(k) submission is approximately 90 days. For more information, visit the official FDA page on Premarket Notification 510(k).
What is a PMA?
A PMA (Premarket Approval) is the FDA’s most rigorous regulatory pathway for medical devices. It is required for most Class III devices, those that sustain or support life, are implanted, or present a high risk of illness or injury.
Unlike a 510(k) submission, which shows that your device is substantially equivalent to an existing one, a PMA requires you to prove your device is safe and effective through scientific evidence, typically including clinical trials.
This makes PMA more complex, expensive, and time-consuming. However, it’s essential for innovative or high-risk devices that lack a valid predicate.
510(k) vs PMA: Key differences
Before choosing a submission path, it’s important to understand the core differences between these two regulatory routes. Here’s a quick comparison of FDA 510(k) submissions and PMA requirements:
Category | 510(k) | PMA |
Device class | Class II | Class III |
Evidence required | Substantial equivalence | Clinical data and scientific evidence |
FDA review time | 90 days | 9-15 months |
Cost | Lower | Significantly higher |
Risk level | Moderate risk | High risk |
How we support your FDA submission
At Quality Smart Solutions, we help you determine the right regulatory pathway and guide you through each step of the process. Our consultants support:
Strategic regulatory assessments
510(k) and PMA preparation and submission
Communication with the FDA
Post-submission support and responses
Whether you’re pursuing a 510(k) submission or preparing a full PMA, we help streamline the process and improve your chances of FDA clearance or approval.
Common questions about FDA 510(k) vs PMA
How do I know if my device needs a 510(k) or PMA?
It depends on your device’s classification and whether a predicate device exists. Generally, Class II devices may follow the 510(k) pathway if substantial equivalence can be shown. Class III devices, on the other hand, usually require PMA due to their higher risk level. A regulatory assessment is the most reliable way to confirm the correct route.
Can I switch from a 510(k) to PMA mid-process?
It’s not recommended. The requirements, timelines, and evidentiary standards differ greatly between the two. Choosing the right pathway early in your planning process is key to avoiding major delays.
Is a PMA always required for Class III devices?
In most cases, yes. However, a few exceptions exist, such as eligibility for the Humanitarian Device Exemption (HDE), depending on the intended use and target population.
Do I need clinical trials for a 510(k)?
Typically not. Most 510(k) submissions rely on bench and performance testing. In contrast, clinical data is usually required for PMA submissions due to the higher level of scrutiny.
What if there’s no predicate and the device isn’t high risk?
If your device is novel but poses a moderate risk and has no existing predicate, the De Novo pathway may be appropriate. This allows you to obtain Class I or II classification without going through the PMA process.
After successful De Novo classification, your device can become a predicate for future 510(k)s. A 510(k) is generally faster and less costly than PMA. According to the FDA, the average review time is about 90 days.
Let’s get your device to market with confidence
Whether you’re pursuing FDA 510(k) pre-submissions or preparing for PMA, Quality Smart Solutions is here to support you. Our team of expert consultants works closely with you to evaluate your device, prepare your submission, and communicate effectively with the FDA.
Visit our medical device services page and contact us to get started.
