Before enactment of the new law, the regulatory requirements for manufacturers of reprocessed single-use devices (the persons who are reprocessing the device) basically depended upon the class of the device. Manufacturers of reprocessed class I and II single-use devices were required to have a 510(k), unless the device was exempt from 510(k). Reprocessors of class III devices were required to obtain premarket approval. Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but rather will need to submit 510(k)s that include validation data. Validation data will also be required for many reprocessors of single-use devices that are currently the subject of cleared 510(k)s. Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application). | 
