The Special 510(k) Program‍

Are you interested in making changes to a device you already have on market?

Some changes don’t require a new 510(k), and others require the completion of another Traditional 510(k). 

But for some changes, a Special 510(k) may be an option. 

Understanding the difference in requirements can be intimidating.

Read on to get some clarification and insight on the Special 510(k) process, and find out if your device meets the criteria for this special pathway.

What is the Special 510(k)?

The Special 510(k) is for a 510(k) submission in which a manufacturer is making modifications to their own legally marketed device when the modifications meet certain criteria.

So, Why Go This Route?

Simply put, the The Special 510(k) pathway speeds up and simplifies the submission process for modified devices to get FDA clearance since the FDA has previously determined that they were safe and effective. 

What does speed up and simplify mean here?

The submission review timeline is only 30 days for a Special 510(k) compared to the typical 90 days for a Traditional 510(k).

How Do I Know If My Device Is Eligible?

‍Fig. 1 — Special 510(k) Flowchart

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Here are the 5 distinct factors used to assess eligibility for a Special 510(k) submission:

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

To fit within the requirements of the Special 510(k) program, the 510(k) must be for a change to the submitter’s own legally marketed predicate device.

This is especially important because the program relies on the following two things:

• Previous FDA review of detailed information 
• This is the review of your original aka Traditional 510(k). FDA is familiar with your product and know that they have found the performance testing acceptable before.
• Manufacturer’s risk analysis
• If the device is not your own, you won’t be able to complete a thorough risk analysis because you won’t know how the changes you made could impact the previously identified risks.
  

B. Are performance data needed to evaluate the change?

Using their design control procedures, manufacturers should consider all applicable information to demonstrate Substantial Equivalence and whether performance data are needed to evaluate any change. 

C. If performance data are required, are there well-established methods to evaluate the change?

If you’re using performance data, then well-established methods need to be used to evaluate the change in order for the change to be appropriate for a Special 510(k). 

A Special 510(k) MUST contain summary information generated from well-established methods instead of the submission and review of complete test reports. 

Minor changes to a well-established method may be acceptable within the context of a Special 510(k), but any major changes to the protocol or acceptance criteria of a well-established method may disqualify your device from going the Special 510(k) route. 

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

If the answer is no, then this device does not qualify under the Special 510(k).

E. Additional Considerations

Since a Special 510(k) runs on an abbreviated timeline when compared to the Traditional 510(k), the following circumstances are NOT appropriate for submission:

• If changes to the device involve more than three scientific disciplines (e.g., biocompatibility, sterility, and electromagnetic compatibility)
• If there are multiple devices with varying changes 
• If a violative inspection report identifying observations related to design control has been issued through a Quality System inspection (Quality System is an FDA Regulation that ensures that products meet requirements and specifications. Read more about QS here)
• If the FDA anticipates a review of test reports in order to establish Substantial Equivalence
  

Special 510(k) Submission Contents Checklist

Use the following checklist to determine whether your Special 510(k) meets submission criteria: 

• Coversheet identifying the submission as a “Special 510(k): Device Modification”
• Name of the manufacturer’s legally marketed device and the 510(k) number of that device appear in the submission contents
• A description of the modified device, a comparison to the cleared device, the indications for use of the device, and the proposed labeling for the device
• Design control activities summary
• The identification of the verification and/or validation activities required to comply with 21 CFR 820.30, which states the requirements for design controls for each class of medical device
• Indications for Use form (Form FDA 3881)
• A statement signed by the individuals responsible for design control activities

Got all that?

If you’re a manufacturer looking to make changes or modify a device that you already have on the market, then the Special 510(k) could be perfect for you.

The process of a Special 510(k) submission is straightforward — if done properly. 

To avoid delays or budget increases, reach out to a Regulatory Consultant who has experience pulling together high-quality submissions and communicating with the FDA to get products cleared. 

Reach out to Proxima CRO to speak with an expert who knows the ins and outs of the Special 510(k) process and can help you get your medical device to market in just a handful of weeks.