MQSA MAMMOGRAPHY EQUIPMENT STANDARDS PHASE-IN PLAN OUTLINED IN PROPOSAL TO REPLACE INTERIM REGS: "FUNDAMENTAL" REQUIREMENTS EFFECTIVE AFTER ONE YEAR
This article was originally published in The Gray Sheet
Executive Summary
FDA is proposing to phase in mammography equipment quality standards over several years in order to soften the economic impact on device firms, the agency says in an April 3 Federal Register notice. The notice outlines FDA plans to amend interim regulations established in December 1993 to implement the Mammography Quality Standards Act of 1992.