This is blog entry summarizing an article published on the FDAeCopy website about the unique challenges of 510k submissions for reprocessed devices.
Mary Vater joined Medical Device Academy as a new regulatory consultant in March 2017. She published her first new blog on our FDA eCopy website today. The blog explains the unique challenges of reprocessed single-use devices when preparing a 510k submission.
Challenges of 510k Submissions for reprocessed devices
There are three areas in particular that challenge reprocessors when preparing a 510k submission for reprocessed single-use devices:
In her article, Mary reviews each of these sections of a 510k submission and identifies both pitfalls and solutions for testing requirements in each of the sections of a 510k.
One of the most important things to know when preparing a 510k submission for a reprocessed device, is whether you need to perform any biocompatibility testing at all. Biocompatibility testing is one of the longest verification and validation tests–as well as the most costly. If you do not modify the device during reprocessing, then you don’t need to perform biocompatibility testing. This article reviews the types of modifications that will require biocompatibility testing.
You also need to develop your own instructions for use and labeling for reprocessed devices. You can reference the original equipment manufacturer’s (OEM) IFU, but you there is specific information needed for reprocessed devices that should be included. This information includes the name and model number of the OEM device.
Finally, it is not enough to provide performance testing data showing that after reprocessing a device it remains equivalent to the OEM device. You must show that the performance remains equivalent after multiple reprocessing cycles. Most devices will deteriorate over time and may only be able to survive a certain number of reprocessing cycles. This testing data needs to be included in your 510k submission.
If you are interested in learning more about how to prepare a 510(k) for a reprocessed single-use device, please visit the FDA eCopy website.