510(k) Submission: Clearance & Selecting a Predicate Device

Medical devices must undergo strict evaluation by the Food & Drug Administration (FDA) to win approval for the US market. To nab a successful 510(k) submission, medical device developers must carefully select a predicate device and support their equivalency claims with carefully crafted documentation.

What is 510(k) clearance?

The 510(k) regulatory clearance pathway is used to demonstrate to the FDA that a device is safe and effective, and substantially equivalent to a legally marketed device.

Product development companies suggesting that their products fit the 510(k) submission requirements must support their equivalency claims by comparing their device to one or more similar legally marketed products.

What is the difference between a 510(k) and premarket approval (PMA)?

Unlike a 510(k) submission (which is designed for devices that can effectively be compared to products that are already on the market), premarket approval (PMA) is used to determine whether or not a new device is safe and effective. Meaning there are no substantially equivalent products already on the market with which a company could draw a comparison.

A PMA typically involves a more in-depth regulatory package, supported by more intense clinical evaluation compared to a 510(k) application.

To determine whether or not a medical device will need to follow a PMA or a 510(k) submission, the FDA divides up medical devices into particular classes based on risk.

• Class I: These devices bring minimal risk to its users and generally do not need any premarket submissions to the FDA.
• Class II: These devices have moderate user risks and require a 510k submission prior to legal entrance to the market.
• Class III: These devices include implanted and life-sustaining medical devices. Because they bring about the highest level of risk to their users, these devices require a PMA submission to win approval.

How to choose a predicate device

“It is important to be thoughtful about selecting a predicate device because picking the wrong one can result in the FDA rejecting your 510(k) submission package.”

When it comes to a 510(k) submission, selecting a predicate device is one of the most consequential decisions a medical device developer will make. The predicate device is the legally marketed product with which a medical device developer compares its experimental device.

Remember, according to the FDA’s definition of a 510(k) submission, the predicate device and the developer’s device must be “substantially equivalent.”

Notably, “substantially equivalent” does not mean identical! In fact, the FDA clearly outlines when products can be considered “substantially equivalent.”

Products can be substantially equivalent if the product:

• Has the same intended use as the predicate and has the same technological characteristics as the predicate
• Has the same intended use as the predicate and has different technological characteristics but does not raise different questions of safety and effectiveness. The information submitted to the FDA must also demonstrate that the device is as safe and effective as the legally marketed product.

It is important to be thoughtful about selecting a predicate device because picking the wrong one can result in the FDA rejecting your 510(k) submission package. You’ll have to reconfigure your application, select a new predicate device, collect new data, and resubmit your application – ultimately delaying your product’s launch.

Also, the FDA makes its decision regarding substantial equivalency by reviewing technological characteristics and performance data, including engineering performance testing, sterility, compatibility, software validation, and more.

So when you’re selecting your predicate, you’re also selecting what kinds of testing you’ll need to run – and that will greatly affect your medical device development efforts.

Related Reading: The Medical Device Development Process: Goddard’s Guide

Integrate Medical Device R&D Expertise with Your 510(k) Submission

Regulatory experts don’t traditionally participate in fast-paced research and product development. Engineers don’t always know how to best navigate detailed medical device regulations. Our team does both!

At Goddard, our product development experts help our clients bridge the gap between R&D and regulatory teams, providing engineering and design expertise that is always in line with what regulators expect of medical device companies.

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