FDA Issues Proposed Rule on Reclassification of In Situ Hybridization Test Systems
June 13, 2025
June 13, 2025
WASHINGTON, June 13 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a proposed rule (Docket No. FDA-2025-N-1243) entitled "Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product." This proposal aims to reclassify in situ hybridization test systems used alongside approved oncology therapeutic products from class III to class II medical . . .