Effect of Reprocessing on Hemodialyzer Performance: How Premarket Data Can be Used to Revise an Existing FDA Guidance Document
M. C. Provost1 and T.C. Lu2, CDRH, FDA, 1ODE, 2OSB, Rockville, MD 20850
Beginning in February 1997, FDA has required hemodialyzer manufacturers to submit 510(k)s seeking approval to relabel their devices for multiple use. The manufacturers collected data on the effects of each recommended reprocessing method on key hemodialyzer performance parameters, including ultrafiltration coefficient and clearance of standard small and large molecules. A database was constructed that contained all of the bench and clinical data submitted in fourteen 510(k) submissions from 12 different manufacturers. Statistical tools were used to analyze the data for significant findings. The results permitted a critical evaluation of the testing requirements described in an existing guidance for multiple use dialyzers. Revisions to the guidance document can then be made that are based on sound science. By limiting the requirements to only the most relevant tests, FDA can minimize review resources and industry can use the least-burdensome path to marketing clearance.