Author: Rachel Benway, Product Manager, Reed Tech
The FDA has placed increased attention on the 510(k) Clearance pathway over the past couple of years which included publishing multiple press announcements from FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren, that were related to updates to the pathway. In this post, I would like to review the statement FDA made on November 26th of 2018 regarding planned steps to modernize the 510(k) program, specifically the idea of “Ineligible Predicates.”
About the FDA 510(k) Program
In this statement they outline a few ways the FDA is planning to modernize the 510(k) program. The statement includes moving to a risk-based regulation of medical products and suggesting new medical devices need to either account for advances in technology or demonstrate that they meet modern safety and performance criteria. They elaborate on the idea of accounting for advances in technology by pointing to the use of old vs. new predicates. They state, “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria.” They found that nearly 20% of 510(k)s are cleared based on predicates that are more than 10 years old. Furthermore, they are considering making a list of these devices public, though I have not seen such a list posted yet.
To reiterate, FDA would like new devices compared to the benefits and risks of more modern technology which would inherently be the case if a newer predicate was used. Additionally, they stated that over 1,700 510(k)s are now listed as ineligible to be used as predicates because the product code on the clearance has since been up-classified. “Through a process known as “up-classifying” … we can and have made ineligible the use of certain devices as legal predicates.”
Now, any product brought to market with one of these device types must have a PMA, not a 510(k). A few examples of these devices are mesh for the treatment of pelvic organ prolapse, automated external defibrillators and metal-on-metal hip implants.
How to determine a 510(k)’s ineligibility
In order to figure out if a 510(k) in the FDA’s 510(k) database is ineligible based on up-classification you have to first click on the FDA Product Code. This will take you away from the 510(k) to a web page with information on the product code. For example, K131525 has product code MKJ and when you click on the product code it takes you to the information about MKJ.
There, you can see that the Device Class is 3 and the Submission Type is PMA. This means this 510(k) cannot be used as a predicate.
Reed Tech has made this part of the 510(k) process more streamlined and efficient. Using our proprietary Reed Tech Navigator™ for Medical Devices database we found 1,646 clearances associated with a Class III product code:
To help with 510(k) research, we’ve added a feature into the Navigator™ application to intelligently flag any 510(k)s that may be ineligible due to up-classification. This feature is a visual cue so someone doesn’t mistakenly choose that clearance as a potential predicate for their clearance application: