Not necessarily. FDA reviewed the types of reprocessed single-use devices that were previously exempt from 510(k), and determined which of these exemptions should be terminated. On April 30, 2003, FDA published a Federal Register notice that included a list of critical2 reprocessed single-use devices whose exemption from 510(k) is being terminated and for which validation data is now required in 510(k)s. For a previously-exempt critical reprocessed single-use device to remain on the market after July 30, 2004, a 510(k) must be submitted, including “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended”, and FDA clearance must be obtained. If a 510(k) is not submitted, or if FDA finds the device to be “not substantially equivalent,” marketing of the device must cease. On June 26, 2003, FDA published a Federal Register notice adding nonelectric biopsy forceps to the list of reprocessed single-use devices whose exemption from premarket notification has been terminated and for which validation data is required. A reprocessed single-use device not included on this list may continue to be marketed without submission of a 510(k). | 
