Understanding FDA’s Special 510(k) Program

They say the only constant in this life is change. Whoever first said it may very well have been discussing medical devices.

When medical devices are modified by the manufacturer, those changes still need to be evaluated by FDA, with the same reason as a new device: to protect the safety of patients and promote greater public health.

So, where do manufacturers turn when updating their own medical device? The answer is with a Special 510(k).

FREE RESOURCE: Click here to download our 510(k) Program Comparison Chart to help you instantly determine which 510(k) program is best suited for your device.

What is the Special 510(k) Program?

The FDA’s Special 510(k) Program is an optional regulatory pathway to market designated for certain medical devices. The program is specifically for manufacturers seeking market clearance when making modifications to their own existing, previously-cleared medical devices. 

Prior to the Special 510(k) Program, manufacturers modifying or updating their own medical device needed to first resubmit their applications for clearance in the form of another 510(k). As stated in 21 CFR 807.81, premarket notification was required when:

The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use.

To simplify the review process, the Special 510(k) Program was introduced in 1998 allowing an expedited market clearance for changes on devices which did not impact its intended use or alter the device’s fundamental scientific technology.  

More recently, the program received an update in 2019 in the form of a final guidance document which greatly expanded the criteria for acceptance of both devices and modifications. Today, the guidance permits that certain intended use and technological changes can be reviewed under a Special 510(k) as long as they are accompanied by well-established qualification methods. 

What are the criteria for a Special 510(k)?

In order for a modified medical device to qualify for the Special 510(k) Program, FDA guidance dictates three basic requirements:

1. The proposed change is submitted by the manufacturer legally authorized to market the existing device,

2. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and

3. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format

Upon first impression, this doesn’t stray too far from the traditional 510(k) pathway, which requires  substantial equivalence to a predicate device. This measure provides both the manufacturer and FDA a standard on which to evaluate the modified device, and along with a competent risk mitigation strategy, it makes up the crux of all 510(k) applications.

The Special 510(k) Program adds a few small wrinkles, not the least of which is that the predicate device used for substantial equivalence is none other than the manufacturer’s original device. 

That’s right: the predicate serves as its own predicate.

How does FDA evaluate device changes in Special 510(k) submissions?

It’s no secret that technology moves the medical device industry further, faster. And whether it’s in standalone devices, software as a medical device (SaMD), or the tools used to modify existing devices, it’s important that the regulatory pathways for medical devices reflect this fast pace.

To keep up with the numerous devices that undergo changes every year, FDA’s guidance on the Special 510(k) Program has had its own changes, too. Per the 2019 update,

FDA now no longer intends to focus on changes that affect indications for use or alter fundamental scientific technology in determining whether the 510(k) is appropriate as a Special 510(k). Instead, FDA’s approach focuses on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.

When reviewing Special 510(k) applications, the FDA review board will look for answers to four key questions.

#1. Is it a change to the manufacturer’s own device?

Before examining any specific changes, FDA must first confirm that the device is the “submitter’s own legally marketed predicate device.” This is primarily the case because the Special 510(k) Program leans almost entirely on the predicate device’s previous application for clearance, especially when it comes time to conduct the risk analysis and the necessary verification and validation. 

FDA takes this point quite seriously, and any modified existing device submitted by a different party will be rescheduled to a traditional 510(k).  If a medical device is submitted under a different name, FDA will ask for an affirmation or statement from the submitter to prove they are legally authorized to market the product.

#2. Is performance data needed to evaluate the change?

The performance data portion of considerations is where we see the importance of design controls come into focus. These controls are crucial to the entire lifecycle of a medical device, especially in the case of  FDA 21 CFR 820.30, which establishes both the risk-based classification system and the subsequent design controls as the determining factors in the pathways to market clearance. 

Design controls require manufacturers to, ”establish and maintain procedures for the validation, or where appropriate, verification, of design changes before their implementation.” This can sometimes mean verification and validation testing. That being said, these processes may not be necessary for a Special 510(k).

In cases where manufacturers determine under their design control procedures that no additional verification or validation testing is necessary to evaluate a change that otherwise requires submission and clearance of a 510(k), manufacturers may submit these changes as a Special 510(k) with a clear rationale supporting their conclusion that no performance data are necessary.

#3. Is there a well-established method to evaluate the change?

The point of the Special 510(k) Program is to help expedite the clearance process for lower-risk changes to medical devices. With this in mind, FDA guidance on the subject allows for manufacturers to skip the inclusion of complete test reports, instead of opting for summary information informed almost exclusively from what they call “well-established methods.”

Well-established methods refer to evaluations that have been established and validated by scientific principles. FDA explains they consider the following as forms of well-established methods:

• The submitter’s methods, protocols, and acceptance criteria used to support the previously cleared 510(k) that can be applied to the subject 510(k);

• Methods found in an FDA-recognized voluntary consensus standard or FDA guidance document;

• Qualified medical device development tools (MDDTs); or

• Widely available and accepted methods published in the public domain, scientific literature, or found acceptable by FDA through the submitter’s own 510(k)-clearance, a granted De Novo classification request, or premarket application (PMA) approval. 

#4. Can the data be reviewed in a summary or risk analysis format?

The focus on risk analysis should come as no surprise; this view is very much in-step with the agency’s shift toward the same kind of risk-based approach found in consensus standards like ISO 14971. 

What are the benefits of a Special 510(k) vs Traditional 510(k)?

It’s commonly known that the 510(k) submission process is the most common pathway for market clearance of medical devices in the US. But, did you know that it’s also the most commonly failed pathway for manufacturers? One recent study found that 97% of recalled devices surveyed had received 510(k) clearance.

At the time FDA’s quality system regulation (QSR) first went into effect, the Traditional 510(k) pathway was in place to evaluate the safety of devices that posed no more than moderate risks and it was only intended for a small percentage of various medical devices that were already being marketed in the US. 

However, because of the lack of a clinical data requirement, this pathway has become an appealing next step for manufacturers eager to get their new devices on the market. That’s why it’s imperative that prior to jumping on a newer, less-known path to clearance like the Special 510(k) you take the time to consider the pros and cons of both 510(k) programs.

Pros & cons of Special 510(k) vs Traditional 510(k)

There are a few key points of differentiation in the Special 510(k) vs Traditional 510(k) debate. Let’s quickly touch on those first:

Pros: 

• More objective

• More predictable for sponsor and FDA

• More well defined submission 

• Less prep time for sponsor and FDA 

Cons:

• No financial incentive

• Same amount of regulatory burden

• Can get complicated with SaMDs

• Paper-based traceability matrices are not effective

Choosing the Special 510(k) Program for your modified medical device provides a much more simplified, straight-to-the-point pathway. The average time quoted by FDA in its guidance document is 30 days, which is far less than the average of five months for a Traditional 510(k).

This simpler approach should provide manufacturers with a more objective, and predictable process. The materials needed for a Special 510(k) are almost identical to the ones used for a Traditional 510(k), and with many of these documents remaining unchanged due to minor adjustments, you should be able to compile the necessary assets quicker than the first time around.

However, changes to software and materials require a review of software validation and biocompatibility. Therefore, two reviewer specialists must coordinate their efforts, and the review cannot be completed in 30 days. In this case, an Abbreviated or Traditional 510(k) must be submitted instead.

FREE RESOURCE: Click here to download our 510(k) Program Comparison Chart to help you instantly determine which 510(k) program is best suited for your device.

Choose a QMS that supports you in achieving regulatory compliance

All of this, of course, depends on the level of care and attention put into the application for the original device. Your medical device regulatory strategy can be made or broken by the traceability and visibility of your QMS solution.

With Greenlight Guru Change Management, you can see the downstream impact of any change and reduce the risk of missing a key element by visualizing the relationships within the MedTech Lifecycle Excellence Platform. 

Get a deep dive into our change process, ask questions, and see how our AI/ML recommendation engine predicts the impact of your changes by getting a free personalized demo →