FOOD AND DRUG ADMINISTRATION ISSUES RULE: HEMATOLOGY AND PATHOLOGY DEVICES; RECLASSIFICATION OF IN SITU HYBRIDIZATION TEST SYSTEMS FOR USE WITH A CORRESPONDING APPROVED ONCOLOGY THERAPEUTIC PRODUCT

WASHINGTON, Aug. 17 -- Food and Drug Administration has issued a rule called: Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product.

The rule was published in the Federal Register on Aug. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subjec...