WASHINGTON, DC (November 8, 2004) – The Food & Drug Administration (FDA) said last week that it has determined that a “significant number” of reprocessed medical devices may no longer be commercially distributed. The FDA made the determination after completing a review of supplemental validation data submitted by firms that reprocess devices originally intended for single use only (SUDs).
The Medical Device User Fee and Modernization Act of 2002 required that reprocessors of certain types of previously cleared reprocessed SUDs must submit supplemental data to the FDA. The agency said that supplemental cleaning, sterility, and functionality validation data were needed in order to determine if these reprocessed devices should continue to be legally marketed. After review, FDA determined that while many of these devices can continue to be legally marketed, a significant number can no longer be commercially distributed.
FDA said it received 44 “Supplemental Validation Submissions,” nineteen of which can continue to be legally marketed. Another 12 were said to be valid for some models, and 11 can no longer be legally marketed. Two submissions are still awaiting a final decision on review of supplemental data. Both were submitted on a staggered schedule to FDA as a result of earlier administrative appeals related to whether the type device required supplemental data, the agency said.
The FDA said that reprocessors of the denied devices may seek agency clearance to market them any time in the future by submitting a new pre-market notification (510k) application demonstrating that the reprocessed product satisfies the agency’s requirements.The FDA did not immediately identify the devices in question or the companies involved.