This content pertains to FDA 510(k) medical device clearances and is intended for the United States.
What does an FDA 510(k) clearance mean?
Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in most cases, a company must compare their product to one already cleared by the FDA and provide evidence that their product is “substantially equivalent” to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective (1). Once “pre-market clearance” is received from the FDA, the device can be distributed commercially immediately.
There are 3 classes of medical device in the US: Class I, Class II, and Class III. For example, a point-of-use water filter is considered a Class II medical device because it presents a moderate amount of risk during use to the patient or caregiver (2). Class III devices present the most risk during use and would include life-supporting devices. Before submitting a 510(k) application to the FDA, the medical device manufacturer must first determine which class of device their product belongs to.
There are important differences between “cleared” and “approved”. When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class III medical devices to be legally marketed, they must undergo a rigorous review and approval process, or pre-market approval (PMA).
An FDA 510(k) cleared medical device is allowed to make claims on the product that have been reviewed and cleared by the FDA. The FDA does not test the product themselves, but instead reviews the data that has been submitted. It also prevents unsubstantiated (false) claims from appearing on labeling or advertising media (3).
Why is an FDA 510(k) Important?
The user of an FDA 510(k) cleared product may be able to feel a certain comfort level with the product that they are using. This is because all medical benefit claims being made have also been scrutinized by expert reviewers and have been deemed safe and effective in the intended use.
An FDA 510(k) cleared product also protects the user from liability. For example, with a point-of-use water filter, a Class II medical device, if the product were to not perform as claimed and had been used according to the indications for use, liability would fall on the manufacturer.
Indications for use (IFU)
The IFU on an FDA 510(k) cleared medical device provides operational instructions to the user to ensure that the device is used properly and is safe and effective during operation. Once cleared, a medical device company with a 510(k) product cannot recommend a product be used in any way counter to the IFU. However, a physician can decide to use a medical device “off-label” if he or she believes it would provide a benefit that outweighs the risk of using it contrary to the IFU. Data can be provided from the manufacturer at the customer’s request so that he or she can determine if the product can safely be used “off-label”.
For a point-of-use water filter, common indications include maximum pressure, maximum temperature, length of life, and handling instructions. However, pay close attention, as many manufacturers also require or suggest water quality testing, on/off cycle counts, or chemicals which cannot be used in conjunction with the product. If these indications are not followed, liability can fall on the end user.
Complaints
If an FDA 510(k) cleared medical device is not performing as intended, the end user can file a complaint with the FDA or the manufacturer.
The user or customer can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or wrongly promoting the performance of their device. This is a straightforward process to ensure that medical devices on the market are being held to strict standards to make sure they are being used safely and effectively.
Examples of regulatory misconduct can be found here.
Things to consider
Before choosing a product with an FDA 510(k) clearance, it is important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It is also important to make sure to read the indications for use to know how to use the product properly. Finally, test data that has been sent to the FDA should be available to the end user, often in a validation guide or test report.
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References
- United States Food and Drug Administration (US FDA). Premarket Notification 510(k). [Updated 2022 Oct 03]. https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
- United State Food and Drug Administration (US FDA). The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510K)]. Guidance for Industry and Food and Drug Administration Staff. [Published 2014 Jul 28]. https://www.fda.gov/media/82395/download
- United States Food and Drug Administration (US FDA). Medical Device Reporting (MDR): How to Report Medical Device Problems. [Updated 2022 Feb 18]. https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct
Author bio
Marissa Khoukaz, Business Development Manager— Hospital Water
Marissa is a Business Development Manager for Hospital Water and manages the prefiltration portfolio globally for Cytiva. She works with high-risk units to reduce waterborne pathogen risk to patients.