FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: IMMUNOLOGY AND MICROBIOLOGY DEVICES; RECLASSIFICATION OF NUCLEIC ACID-BASED TEST SYSTEMS FOR USE WITH A CORRESPONDING APPROVED ONCOLOGY THERAPEUTIC PRODUCT; PROPOSED AMENDMENT; PROPOSED ORDER; REQUEST FOR COMMENTS

WASHINGTON, Nov. 25 -- Food and Drug Administration has issued a proposed rule called: Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments.

The proposed rule was published in the Federal Register on Nov. 25 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket...