TISSUE CULTURE MEDIA PRODUCTS WOULD HAVE 510(K)s COVERING CELL/TISSUE CULTURE PROCESSING UNDER AMDM PLAN; LABELING WOULD WARN OF OFF-LABEL USE
This article was originally published in The Gray Sheet
Executive SummaryTissue culture media manufacturers would submit 510(k)s for "families" of products under an Association of Medical Diagnostic Manufacturers proposal intended to address FDA concerns about off-label use.
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