Zdrowie i gospodarka · 08/07/2003

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single-Use Devices

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information will be used by FDA to determine whether reprocessed single-use devices (SUDs) are substantially equivalent to legally marketed predicate devices. FDA is requesting this emergency processing under the PRA to implement the statutory provision under section 302 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).