FDA Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004
This guidance document describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on how the agency will implement this new section with respect to the submission of validation data in 510(k)s for reprocessed Single Used Devices
FDA Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors
FDA now recommends implementation of quality assurance and quality control procedures that involve use of external control reagents beyond those provided by the test kit manufacturer in order to contribute to overall testing accuracy and therefore to blood safety.