New FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.
In 2018, FDA cleared 3,000+ medical devices via the 510(k) process. An overwhelming majority of those devices (82%) went through the Traditional 510(k) process. Only 60 (less than 2%) went through the alluring “Abbreviated 510(k)” process. Why? Well, frankly there is very little that is “abbreviated” about that process, as it still requires the submitter to demonstrate “substantial equivalence” to a suitable predicate device.
Now, however, FDA has finally done something to provide relief from this requirement – it released a new guidance in January 2019 that supports the agency’s regulatory mandate to offer the “least burdensome approach” to manufacturers.
FDA finally recognized that the burden associated with preparing (manufacturer) and reviewing (internal FDA) predicate comparisons on devices that have been on the market for decades, have established performance standards, and are well-understood outweighed any potential contributions to patient or user safety.
The “Safety and Performance-Based Pathway” is an expansion of the Abbreviated 510(k) process. It is important to note that it will not replace the Abbreviated 510(k) pathway but will instead run in parallel. The Abbreviated 510(k) relies on the use of FDA guidance documents, special controls, and FDA-recognized consensus standards (examples: IEC 60601-1, ISO 14971:2007) and requires comparison to an appropriate predicate device(s).
How This Expanded Concept of the Abbreviated 510(k) Program Works
In a nutshell, the new pathway essentially allows for very well-established devices to demonstrate their safety and effectiveness without requiring the submitter to perform direct comparison testing to a predicate device. Here’s what FDA has to say about it:
“If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find that the new device is as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s).”
Is This a Shortcut?
Sort of. Manufacturers will still need to meet all the requirements outlined in FDA published guidance documents. You will still need to follow consensus standards and perform appropriate performance testing. However, regulatory specialists utilizing this pathway will no longer have to require their companies to procure and conduct direct comparison testing to a competitive predicate device. That saves time and money.
The format of the submission will be the same as a typical 510(k) and all sections must be completed. In addition, FDA expects you to submit a Declaration of Conformity plus a summary of the data, testing protocols, and/or other underlying data, as appropriate, to prove that your device meets appropriate tests outlined in guidance documents.
Ready? Not So Fast…You Can’t Use It Quite Yet
Why not? Because as of the January 2019 publication date of the guidance, FDA has not yet published a list of the actual devices that are appropriate for this new pathway. So, even if you have a device that has been on the market for a long time and you believe its performance is well understood, there are no guarantees that FDA will agree it qualifies for this new regulatory pathway. The agency plans to publish the list of devices on their website but have not given any indication of when that will happen. FDA also says they will list the guidance documents that identify the performance criteria for each device type and the testing methods recommended in the guidelines. Thus, companies lucky enough to make products that qualify for this pathway should find the path to clearance to be well defined and easier to follow. FDA has also said they will change this list over time, even removing some devices if needed. However, once a device is cleared via this pathway, the FDA has stated that the device may retain its 510(k) clearance unless there is a safety concern.
Let Oriel STAT A MATRIX Assist with 510(k) Training or Preparation
If you’re ready to take the next step and want a deeper look inside the 510(k) preparation process, consider our training class held in various cities. Our team of FDA consultants can also assist you in all aspects of 510(k) strategy or preparation. Let us know how we can help you!