What is 510K
510(k) clearance is a premarket submission process required by the Food and Drug Administration (FDA) for certain class II and class III medical devices before they can be marketed in the United States. The process is named after the section of the Food, Drug and Cosmetic Act that describes it (21 U.S.C. § 360(k)) and it is also known as “Premarket Notification” or “PMN”. The process is intended to provide reasonable assurance of the safety and effectiveness of the medical device.
The 510(k) clearance process requires the medical device manufacturer to submit a premarket notification (510(k)) to the FDA, demonstrating that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device(predicate device) that is not subject to premarket approval. The 510(k) must demonstrate that the device to be marketed has the same intended use and the same technological characteristics as the predicate device, or has different technological characteristics and the information submitted in the 510(k) demonstrates that the device is as safe and effective as the legally marketed device.
Types Of 510K(s)
There are three types of 510(k) submissions that medical device manufacturers can make to the FDA: Traditional, Special, and Abbreviated. Each type of submission has its own specific requirements and is used for different types of medical devices.
Traditional
A Traditional 510(k) is a premarket notification submitted to the FDA for a medical device that does not have a legally marketed predicate device to which the device can be compared. This means that there is no similar device that is already on the market for which the FDA can use as a reference to evaluate the new device. The Traditional 510(k) must demonstrate that the device is safe and effective for its intended use through a comprehensive evaluation of the device’s design, performance, and labeling. This type of submission requires more data, including bench and animal testing, which can be more time-consuming and costly compared to the other types of 510(k)s.
Special
A Special 510(k) is a premarket notification submitted to the FDA for a medical device that has unique characteristics or that poses unique questions of safety and effectiveness. This type of submission is used for devices that do not have a legally marketed predicate device and that require additional review by the FDA because of the device’s potential risk to the public health.
Examples of devices that may require a Special 510(k) include those that are intended for use in supporting or sustaining human life, that are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury.
Abbreviated
An Abbreviated 510(k) is a premarket notification submitted to the FDA for a medical device that has the same intended use and the same technological characteristics as a legally marketed predicate device. This type of submission is used for devices that are substantially equivalent to a predicate device already on the market and does not require the same level of data as a traditional 510(k). The Abbreviated 510(k) must demonstrate that the device is at least as safe and effective as the predicate device, and it can rely on the safety and effectiveness data of the predicate device
510k vs PMA
510(k) clearance and Premarket Approval (PMA) are both premarket submission processes required by the Food and Drug Administration (FDA) for medical devices before they can be marketed in the United States. However, the two processes have different requirements and are used for different types of medical devices.
510(k) clearance is a less rigorous process that is used for devices that are considered to be “substantially equivalent” to devices that are already on the market. To obtain 510(k) clearance, a device manufacturer must submit a premarket notification (510(k)) to the FDA demonstrating that the device is as safe and effective as a legally marketed device.
PMA, on the other hand, is a more rigorous process that is used for devices that are considered to be “new” or “innovative” and that may pose a greater risk to public health. To obtain PMA, a device manufacturer must submit a Premarket Approval Application (PMA) to the FDA demonstrating that the device is safe and effective through clinical trials and other scientific data.
| 510(k) Clearance | Premarket Approval (PMA) |
| Substantially equivalent to a legally marketed device | New or innovative device |
| Premarket Notification (510(k)) submission | Premarket Approval Application (PMA) submission |
| Less rigorous review process | More rigorous review process |
| Less data required | More data required, including clinical trials and scientific data |
Above is a comparison of 510K VS PMA.
510k submission process
Confirm classification of medical device
The first step in the 510(k) submission process is to confirm the classification of the medical device. Medical devices are classified into three classes (I, II, III) based on their level of risk. Class I devices pose the lowest risk, while Class III devices pose the highest risk. Understanding the classification of the device will help determine the type of 510(k) submission that is required to the FDA.
Identify three-letter product code and regulation number for your device
The three-letter product code and regulation number for the device, which are used by the FDA to identify and classify different types of medical devices, should be identified. This information can be found on the FDA’s website, and it is important to ensure that the correct product code and regulation number for the device is identified before the 510(k) submission process begins.
Select a predicate for comparison
If the device is considered to be substantially equivalent to a legally marketed device, a predicate device for comparison should be selected. A predicate device is a device that is already on the market and that has the same intended use and technological characteristics as the device. This will be used as a reference point for the FDA to evaluate the device’s safety and effectiveness.
Perform clinical studies and performance testing
Depending on the type of device and the level of risk it poses, clinical studies and performance testing may be required to demonstrate the safety and effectiveness of the device. This data will be included in the 510(k) submission.
Gather documents for 510k application and submit to FDA
Once the above steps have been completed, the necessary documents for the 510(k) submission should be gathered, including the premarket notification, test reports, and any other relevant information. Once the submission is complete, it should be submitted to the FDA for review.
Why Us?
By choosing Innovenn’s 510(k) consulting services, medical device manufacturers can benefit from our extensive experience and knowledge of the regulatory requirements and expectations of the FDA. Our team can help ensure that the submission is complete, accurate, and compliant with all relevant regulations, increasing the chances of a successful outcome. Innovenn’s consulting services can help medical device manufacturers save time and resources, and reduce the risk of delays or costly deficiencies in the FDA review process. If you are interested in learning more about Innovenn’s 510(k) consulting services and how we can help you bring your medical device to market, please contact us directly to discuss your specific needs.
