Subject: HELP TO REMOVE IN VITRI DIAGNOSTICS FROM FDA

From: "B.B." <[email-masked]>
Date: 20 May 1995 03:01:51 GMT

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