Regulatory Approval Processes for Medical Devices in the U.S.: The Difference Between 510(k) and PMA
Table of Contents
- What is 510(k)?
- What is Pre-Market Approval (PMA)?
- Why do we need to go through approval processes like 510(k) or PMA?
- Key FDA Documents
- When to submit a new 510(k) for a change to an existing device?
- Summary
Are you planning to bring a medical device to the U.S. market? Then it’s important to understand the rules set by the U.S. Food and Drug Administration (FDA).
Before you can sell your device in the U.S., it needs to be approved by the FDA. There are two main ways to do this - the 510(k) process and Pre-Market Approval (PMA). Each pathway has its own steps and requirements, and the right one depends mostly on the type of device you’re making and how risky it might be for patients or users.
In this article, we’ll give you a clear overview of both options, explain how they differ, and help you understand when each one is used—and what the process involves.
What is 510(k)?
510(k), officially called Premarket Notification, is an approval process intended for medical devices with low to moderate risk (Class I and II). In this process, the manufacturer must demonstrate that the new device is substantially equivalent to an already approved product (known as a predicate device).
When is it used?
- When introducing a new product to the market
- When making a significant modification to an existing device (e.g., its technology, material, or software)
What is Pre-Market Approval (PMA)?
PMA – Pre-Market Approval – is a process designed for high-risk devices (Class III), such as pacemakers, artificial hearts, or implants. This process is more demanding and requires clinical trials, laboratory testing, and evidence proving the device’s safety and effectiveness.
When is it used?
- When there is no similar (predicate) device already on the market
- When the device involves new technology or presents a higher risk
Why do we need to go through approval processes like 510(k) or PMA?
Every medical device that is to be placed on the U.S. market must be approved by the FDA (U.S. Food and Drug Administration). Without this approval, the product cannot be legally sold or marketed in the U.S.
The approval process is meant to ensure:
- Safety and effectiveness – verifying that the device doesn’t harm patients and performs as intended
- Quality assurance
- Patient protection - making sure the device doesn’t introduce new, unexpected risks.
What is a significant change and what role does it play in the approval process?
Once a device has been approved (e.g., through the 510(k) process) and the manufacturer wants to make a change, they must evaluate whether the change is “significant”.
- If the change is not significant, the device can continue to be marketed under the original clearance.
- If the change is significant, a new submission is required – such as a new 510(k) notification – because the change could affect the device’s safety, effectiveness, or intended use.
Example of what is and isn’t a significant change:
If you have a vascular catheter and you only change its color, this is typically not a significant change.
However, if you change the material that comes into contact with blood, this is considered a significant change, because it could affect the device’s biocompatibility and safety.
Key FDA Documents
In the FDA approval process, the agency sets clear rules on how to proceed based on the risk classification of the medical device. To help manufacturers navigate the process, the FDA provides official guidance documents that explain in detail how to choose the correct approval pathway and what supporting documentation is required.
Below are links to the two most important documents that every medical device manufacturer should be familiar with:
1. Deciding When to Submit a 510(k) for a Change to an Existing Device
https://www.fda.gov/media/99812/download
What does this document include?
This guidance is intended for manufacturers who already have an FDA-cleared device (via the 510(k) pathway) and are planning to make changes to it. The FDA explains in detail how to evaluate whether the change is significant enough to require a new 510(k) submission.
2. Premarket Approval (PMA)
https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
What does this document include?
This webpage outlines the full process of PMA (Pre-Market Approval) – the most stringent FDA approval pathway, required for high-risk devices (Class III).
When to submit a new 510(k) for a change to an existing device?
- If the change is significant → you must prepare and submit a new 510(k) to the FDA
- If the change is insignificant → it is sufficient to document the change internally and retain the records in your Quality Management System (QMS)
- If you are unsure – it is recommended to consult a regulatory expert or request a Pre Submission meeting with the FDA
Summary
If you are planning to launch a medical device on the U.S. market, it is crucial to correctly determine whether the 510(k) process will suffice or if the more demanding Pre-Market Approval (PMA) is required. Each of these approval pathways has clearly defined rules and criteria.
Choosing the wrong pathway may lead to the FDA rejecting your application, which can significantly impact your project timeline and the product’s market launch.
As mentioned earlier, 510(k) clearance typically takes 90 to 180 days. The PMA process is significantly longer and may take several months to over a year, depending on the complexity of the device and the need for clinical data.
If the FDA rejects the submission due to an incorrectly chosen pathway or insufficient documentation, it may be necessary to start the process over.
This kind of mistake can lead to:
- delays of several months to a year
- increased costs for preparing new documentation
- or even loss of market opportunity for the device
That is why we strongly recommend working with experts in medical device regulatory affairs, who can help you assess the product’s risk class, choose the appropriate strategy, and ensure accurate and complete FDA submissions on the first try.