Hemodialyzer reuse 510(k)s need clinical data from at least 12 patients, FDA says.
This article was originally published in The Gray Sheet
HEMODIALYZER REUSE LABELING 510(K) SUBMISSION DEADLINE will be addressed in a letter slated to be sent to manufacturers of the devices by the end of November, according to FDA. The agency is issuing the letter following completion of its 510(k) guidance on hemodialyzer reuse labeling, which was released the week of Oct. 16.
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