Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

You may also be interested in...

ODE Division Director Ulatowski Appointed Office Of Compliance Chief

Center for Devices & Radiological Health veteran Timothy Ulatowski will assume the position of Office of Compliance director starting Jan. 22, pending final sign-off by FDA Commissioner Mark McClellan

GAO Oversight Of FDA Performance Included In House Device User Fee Bill

FDA's ability to achieve timely review of premarket applications will be closely monitored by Congress and industry if the agency implements a planned medical device user fee program

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...

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts