Some reprocessed SUDs not equivalent, says FDA

The Food and Drug Administration (FDA) has determined that some reprocessed single-use devices (SUDs) no longer can be distributed commercially.

The Medical Device User Fee and Modernization Act of 2002 required reprocessors of certain types of previously cleared reprocessed SUDs to submit supplemental data to the FDA. For a list of the devices that are no longer legally marketed, go to www.fda.gov/cdrh/reuse/svs/svslist-nolegal.html. For a list of devices that are legally available, go to www.fda.gov/cdrh/reuse/svs/svslist-legal.html. For frequently asked questions, go to www.fda.gov/cdrh/reuse/svs/faq.html.

One of the frequently asked questions is whether a customer should continue to use in-stock, reprocessed SUDs once the reprocessor can no longer distribute as a result of a not substantially equivalent (NSE) letter or a letter acknowledging withdrawal. The FDA says that upon receipt of a NSE letter or a letter acknowledging withdrawal, the device subject to the letter may no longer be legally marketed. You may contact the reprocessor to learn about any plans for retrieval or withdrawal of in-stock devices.

If you have additional questions, the FDA recommends that you first contact the SUD reprocessor for information about the device. You also may contact the 510(k) staff within the Office of Device Evaluation, Center for Devices and Radiological Health (CDRH) at (301) 594-1190 or the Office of Compliance, CDRH, at (240) 276-0100.