Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues draft guidance on classification product codes. Black box warning required for ovarian adnexal mass test systems. More regulatory news.
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Regulatory News In Brief
FDA issues guidance on product classification codes and molecular diagnostic instruments with combined functions. More regulatory news.
Regulatory News In Brief
FDA discusses import review process
FDA Clears Steris Corp's New Device Sterilizer - But Not For Sterilization?
Infection prevention firm Steris Corporation received 510(k) clearance for its new System 1E liquid chemical sterilant processing system April 5 after pulling the system's predecessor from the market a few months ago