FDA Extends Deadline for SUD Reviews
The U.S. Food and Drug Administration (FDA) has extended the review deadline of Supplemental Validation Submissions (SVSs) by 90 days to November 1, 2004. The new deadline will give reprocessors who have submitted good but inadequate information the opportunity to submit additional supporting documentation for their devices and give FDA reviewers time to complete the SVS review.
Under the Medical Device User Fee and Modernization Act of 2002, reprocessors of single-use devices (SUDs) deemed "critical," were required to submit additional information about cleaning, sterilization, and functionality for FDA to review in order for their devices to continue to be commercially marketed. SVSs were due to FDA by the end of January 2004 and the deadline for the review of these submissions was July 31, 2004.
Additional details regarding the review of SVSs will be posted on the Reuse FAQ page by August 13, 2004.
Source: Association for the Advancement of Medical Instrumentation (AAMI)
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