FDA Stresses Early Discussion Of Foreign Data In Post-MDUFMA World
This article was originally published in The Gray Sheet
Executive Summary
CDRH is urging sponsors to schedule pre-filing meetings with the device center, especially if firms plan to use data collected in trials conducted outside the U.S
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Regulatory News In Brief
Japanese administrative reform: Ministry of Health, Labor and Welfare will merge the governmental agency responsible for evaluating claims of substantial equivalence for devices with its counterpart for drugs. Though the name of the new national institute has not been determined, the Japan Association for the Advancement of Medical Equipment and the Organization for Pharmaceutical Safety & Research, both currently administered by the Pharmaceutical and Medical Device Examination Center umbrella agency, are expected to merge with PMDEC in 2004. Additional revisions to the Japanese Pharmaceutical Affairs Law, anticipated in May, will introduce risk-based classification and a "new approach to approval and license." As part of the reforms, JAAME is "studying the certification process of notified bodies in Europe, [will] introduce third-party certification system once conformity is established by MHLW, and will submit an application to be a certifying body," Executive Director Hiroyuki Yanai says March 19 at the Regulatory Affairs Professionals Society Medical Device Conference in San Francisco. Implementation of the new systems could take one to three years...