- Why Us
If your medical device falls under premarket submission criteria, there are three types of 510(k) that you can choose from.
Your 510(k) submission could go down the Special, Abbreviated, or Traditional pathway and it’s important that you understand what qualifies under each.
Here, we’re comparing the three types of 510(k) programs to help you identify which option is the most applicable to your device:
The Special 510(k) program was first developed in 1998 as an alternative to the traditional pathway. As the FDA says of their Special 510(k) guidance:
The intent of this guidance is to describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).
In other words, the Special 510(k) is for medical devices that are already cleared under a Traditional 510(k) and have had significant changes made so that they need to go through clearance again.
This most recent guidance is an update to allow for review of changes that affect the device’s intended use or alter the device’s fundamental scientific technology. Previously, those sorts of changes weren’t allowed under the Special 510(k).
Under the new guidance, the FDA focuses on the methods used to evaluate the changes. They want to know that those methods are well-established and that results can be sufficiently reviewed in a summary or risk analysis format. FDA explains this further, noting that:
A Special 510(k) would generally not be appropriate for devices that manufacture a biological product at the point of care, because there would likely be no well-established method to evaluate such changes and/or the performance data would not be reviewable in a summary or risk analysis format.
FDA recommends asking these key questions when considering whether a device should should use the Special 510(k) program:
Is it a change to the manufacturer’s own device?
If no, then Special 510(k) should not be used.
Are performance data needed to evaluate the change?
“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.” (FDA Special 510(k) Guidance)
Is there a well-established method to evaluate the change?
If not, then device doesn’t qualify under the Special 510(k).
Can the data be reviewed under a summary or risk-analysis format?
If not, then device doesn’t qualify under the Special 510(k).
On page 13 of the Special 510(k) guidance document, they also provide a number of scenarios under which they believe it is not appropriate to submit a Special 510(k). Some of these scenarios include:
When evaluation of the change(s) to the device generally involve greater than three scientific disciplines (e.g., biocompatibility, sterility, electromagnetic compatibility);
For multiple devices with unrelated changes as described in the FDA guidance: Bundling Multiple Devices or Multiple Indications in a Single Submission;
When a recent QS inspection has resulted in the issuance of a violative inspection report identifying observations related to design controls that are relevant to the design changes under review in the 510(k). If a manufacturer believes such violations are unrelated to the subject 510(k), they should provide a rationale for why the 510(k) should still be appropriate for review under the Special 510(k) Program.
Appendix A of the guidance outlines the recommended content of the Special 510(k) submission. Appendix B provides examples of changes, and steps through questions 1-4 above for each of those changes, which can be helpful in determining if your device change(s) qualify for a Special 510(k).
FDA will usually respond within 30 days to a Special 510(k) submission and will let you know if they want it to go down the traditional route instead.
The Abbreviated 510(k) program was also developed in 1998 as an alternative to the traditional path. Manufacturers can choose to submit an Abbreviated 510(k) when the submission relies on:
FDA guidance document(s),
Demonstration of compliance with special control(s) for the device type, or
Voluntary consensus standard(s).
The Abbreviated 510(k) submission must include the sections that are in the Traditional 510(k), but as a manufacturer, you can choose to provide summary reports on the use of guidance documents, demonstration of compliance with special controls for the device type, or declarations of conformity to the FDA's recognized standards to facilitate the review of a submission. In other words, it’s a “paper comparison,” showing substantial equivalence to a guidance or standard.
“Abbreviated” doesn’t mean less work. You still need to provide all the relevant 510(k) sections, it’s just that you may be able to prove substantial equivalence via a standard, rather than by having to do additional testing or argue using a predicate device.
Why would you use the abbreviated pathway? Sometimes it’s just easier to prove your case against a standard than against a predicate device. Some predicate devices are just very challenging in terms of clearly arguing your case. The standard might be a much clearer pathway for you in these cases.
The review period for the Abbreviated 510(k) program (subject to the documented Refuse to Accept guidelines), is generally within 90 days of submission.
Note: Oftentimes the Abbreviated 510(k) will have a longer review period than the Traditional 510(k).
The Traditional 510(k) pathway is the most commonly used of the 510(k) types. The essence of the traditional route is to show substantial equivalence to an existing or predicate device.
We’re not going to sugarcoat it - for anyone looking in at the 510(k) for the first time, it can appear to be a daunting process. Many of the Medical Device Gurus on our team have worked in the consulting field and helped medical device companies to put together their 510(k) submission. To that end, you can learn more about the process in our Step-by-step Guide to Preparing your 510(k) Submission.
The Traditional 510(k) is used for any original device that has not been previously cleared and is not required to go through the PMA process. The Traditional 510(k) is also used for a change to a previously cleared device that does not qualify for a Special 510(k).
You must be able to point to predicate devices with respect to indications for use and technological characteristics. The FDA’s guidance document, Evaluating Substantial Equivalence in Premarket Notifications (510k) contains their requirements for this.
These three types of 510(k) submissions are only three out of around seven possible pathways for bringing a medical device to market in the United States.
The three 510(k) pathways have certain things in common, such as the need to document your “evidence” very accurately and clearly. The time to start doing this is ASAP - you don’t want to be scrambling to put the paperwork together right when you want to make your submission.
This is why it’s important to use the best QMS solution for medical device companies. Greenlight Guru has created an electronic QMS that makes updating and storing your documentation a breeze.
Importantly, when it comes to making your 510(k) submission, you’ll always know you’re looking at the most up-to-date version of your documents. There’s no more chasing up forms out of desk draws or across different sites. Get your free demo of Greenlight Guru QMS software →
Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software
Wade Schroeder is a Medical Device Guru at Greenlight Guru with a noticeable enjoyment of medical device product development processes. As an electrical engineer by trade, he began his career developing medical exam procedure chairs and later designing IVD devices. He has been a risk management enthusiast since the...