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

WASHINGTON, June 11 -- Food and Drug Administration has issued a proposed rule called: Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product.

The proposed rule was published in the Federal Register on June 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is a...