The Food and Drug Administration (FDA) announced that it has completed its review of supplemental validation data submitted by firms that reprocess medical devices originally intended for single use only (SUDs).
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required that reprocessors of certain types of previously cleared reprocessed SUDs must submit supplemental data to the FDA. Supplemental cleaning, sterility, and functionality validation data were needed for FDA to review in order to determine if these reprocessed devices should continue to be legally marketed.
After a careful review of the submitted data, FDA has determined that while many of these devices can continue to be legally marketed, a significant number can no longer be commercially distributed.
Some five firms submitted supplemental data to the FDA. Some submissions were for a single device; others were for as many as several hundred device models. Some 1,800 models of reprocessed single use devices required validation data under MDUFMA.
FDA received 44 Supplemental Validation Submissions (SVSs). Based on a review of the submitted data, FDA found 19 SVSs to be Substantially Equivalent (can continue to be legally marketed), 12 SVSs Substantially Equivalent for some models, and 11 SVSs to be Not Substantially Equivalent or withdrawn by the reprocessor after submission (can no longer be legally marketed). Two SVSs are still awaiting a final decision on review of the supplemental data. These two SVSs were submitted on a staggered schedule to FDA as a result of earlier administrative appeals related to whether the type device required supplemental data.
Reprocessors of no longer legally available reprocessed SUDs may seek FDA clearance to market them any time in the future by submitting a new premarket notification (510k) application to the FDA demonstrating that the reprocessed product satisfies the agency's premarket requirements.
FDA is scheduling follow-up inspections of these firms to ensure compliance with these determinations and will initiate enforcement actions as required.