From owner-diagnostics@net.bio.net Fri May 19 23:00:00 1995 Path: biosci!bloom-beacon.mit.edu!news.starnet.net!wupost!howland.reston.ans.net!nntp.crl.com!decwrl!svc.portal.com!news1.best.com!usenet From: "B.B." Newsgroups: bionet.diagnostics Subject: HELP TO REMOVE IN VITRO DIAGNOSTICS FROM FDA >>>> Date: 20 May 1995 03:10:30 GMT Organization: BEST Internet (415) 964-2378 Lines: 62 Message-ID: <3pjmj6$r1a@news1.best.com> NNTP-Posting-Host: biotech.vip.best.com REPORT ON MDMA’S SUMMIT FOR FDA REFORM On May 11-13, 1995 the Medical Devices Manufacturers Association, MDMA, held the SUMMIT FOR FDA REFORM in Washington DC. A “ Blueprint for FDA Reform”, advanced by MDMA, was discussed at the meeting. During the celebration of the SUMMIT, over 70 congress representatives were approached by members of MDMA who officially delivered the Blueprint for FDA Reform, several representatives offered to translate the blueprint into legislative language and introduce it to Congress. The speaker of the House, Newt Ginrich asserted that the House will pass FDA reform containing most of the issue outlined in the Blueprint. It appears that FDA REFORM will continue to be a hot issue at Capitol Hill. The SUMMIT For FDA Reform is supported by the following organizations, representing 700 companies and constituting The National Medical Device Coalition:. · American Electronics Association · Association of Medical Diagnostics Manufacturers · IVD Manufacturers Coalition · Utah Biomedical Industry Council · Indiana Medical Device Manufacturers Council · Independent Reagent Manufacturers Association · Medical Device Manufacturers Association · Dental Implant Manufacturers Association · Contact Lens Manufacturers Association · Joint Council of Immunohistochemical Manufacturers The in vitro diagnostic industry should not continue to be regulated with the same measure used to control drugs. There is a clear and profound difference between pharmaceuticals and in vitro diagnostics (IVD). The in vitro diagnostic industry, integrated in its majority by small companies, has been placed under the FDA agency for too long, in detriment of both health care and manufacturers. The present regulatory arrangement is unfit for our industry and tends to hamper the implementation of new technologies in health care. We would like to encourage all of those who believe it is time to separate in vitro diagnostics from under the FDA’s jurisdiction, to help by supporting this movement. It is important for you to voice your opinion in support of immediate changes of the FDA. This action must take place NOW. Contact your District’s House Representatives and Senators, introduce them to the Blueprint for FDA Reform and request they support FDA reform including removal of in vitro diagnostics from FDA. Copies of the MDMA blueprint For FDA Reform can be obtained directly from NMDC The National Medical Device Coalition 1575 Eye Street, N.W. Suite 500 Washington, DC 20005 Phone: 202-898-5700 .