January 10, 2022

The 510(k) Program – All About This Submission Type

The 510(k) Program – All About This Submission Type

So, you’ve got a product you want to get to market?

Kind-of, sort-of familiar with the FDA process in getting product clearance but need more insight?

Well, you’re in the right place. 

Here’s a basic overview of the 510(k) program and its different subtypes.

First things first… what is a 510(k)?

The 510(k) program is one of the options for pre-market notification and getting your product to market. 

This isn’t the only pathway but based on what your device is and its risk-level (specifically, moderate to low-risk devices)— this may be the best option for your product.

Types of 510(k)s

There are three types of 510(k) submissions types: 

  • Traditional 510(k)
  • Abbreviated 510(k)
  • Special 510(k)

Let’s break down each one to see their similarities and differences.

But.. before we get into the different 510(k) types. There are some important phrases aka FDA jargon we need defined to fully understand the components of the 510(k).

Technical term number one: Predicate Device

A predicate device is a legally marketed device that previously went through one of the 510(k) submission process types. 

Records of these devices are housed in the FDA 510(k) database.

Regardless of which type of 510(k) you’re using, it will need a predicate device that demonstrates substantial equivalence.

Substantial what?

Yes, that’s the next phrase you need to know to understand parts of this process.

Technical term two: Substantial Equivalence

Substantial Equivalence (SE) is a determination made for a medical device that has shared similarities with a device already on market in the US (aka a predicate). 

SE shows that the new device is as safe and effective as the predicate device it is being compared to.

An SE device fits into one of these two categories:

  • It has the same intended use and the same technological characteristics as the predicate

OR

  • It has the same intended use as the predicate but has different technological characteristics that don’t change the safety or effectiveness of the device.


With that information, the FDA shows that the device is as safe and effective as the legally marketed predicate.

Okay, now with that information down, let’s move onto the three different subtypes of 510(k) submissions:

Traditional - The Traditional 510(k) is used for any original 510(k) or a new submission that has identified a predicate device to which substantial equivalence has been demonstrated. 

Abbreviated - The Abbreviated 510(k) is used for submissions that rely on FDA guidance documents, demonstrations of compliance, and voluntary consensus standards.

Special – The Special 510(k) is used when a manufacturer is making modifications to its own legally marketed device. 

A Special 510(k) is only used if the modification does not alter a device’s intended use or its technology.

Is a 510(k) right for my device? Pre-submission can help!

Not sure if you have it all figured out?

A Pre-Submission can be submitted before your 510(k) submission to determine if the 510(k) is the right path for your medical device.

It assists you and other stakeholders in receiving feedback about the medical device with the objective of identifying any future obstacles early on in the process.

Need more insight on this process?

Thinking about whether a 510(k) is right for your product? 

If you have identified a predicate device, a 510(k) could be the ideal path in bringing your product to the public. 

Even if you haven’t identified a predicate or if you need general guidance on this process or any other regulatory submission, it’s especially important to engage with a regulatory specialist that can assist you in determining if and which 510(k) type fits your needs. 

Reach out to Proxima CRO to speak with an expert that can get your product on the road to market.

Reference

  1. U.S. Food & Drug Administration: Center for Devices and Radiological Health. (2018, January 04). The 510(k) program - transcript. Retrieved April 02, 2021, from https://www.fda.gov/training-and-continuing-education/cdrh-learn/510k-program-transcript
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