Subject: FDA REFORM FOR IN VITRO DIAGS. DELIVERED TO US CONGRESS

From: "B.B." <[email-masked]>
Date: 14 May 1995 04:29:53 GMT

ON MAY 11-13, 1995, THE MDMA'S BLUE PRINT FOR FDA REFORM
WAS DELIVERED TO US CONGRESS REPRESENTATIVES
SEE ANNOUNCEMENT BELOW.

WHAT WOULD
YOU GIVE
TO SHAPE
TOMORROW’S
REGULATORY
ENVIRONMENT?

MDMA
MEDICAL DEVICE
MANUFACTURERS
ASSOCIATION

YOUR VOICE
WILL BE
HEARD
!

GIVE THE MDMA 3 DAYS. . .
of your time this coming May 11-13.
With the new legislative environment,
real reform is possible.
Come be a part of it.
Interact with leaders from
the FDA, Capitol Hill, and Industry
in an exchange of
ideas about change.

MEDICAL DEVICE
MANUFACTURERS
ASSOCIATION
REGULATORY REFORM
SUMMIT
May 11-13, 1995 9 Washington, DC   Ramada
Plaza Hotel

INVITEES FROM CAPITOL HILL:
 	House Speaker Newt Gingrich
 	Senator William Frist, MD
 	Senator Orrin Hatch
 	Senator Nancy Kassebaum
 	Senator Rod Grams
 	Congressman David McIntosh
 	Congressman Thomas Bliley
 	Congressman Jim Ramstad
 	Congressman Joe Barton
 	Congresswoman Anna Eschoo

INVITEES FROM THE FDA:
 	Dr.  Burce Burlington, Director, CDRH
 	Dr. Susan Alpert, Director, ODE
 	John Stigi, Director, DSMA

INVITED INDUSTRY SPEAKERS:
 	Wayne Barlow, Wescor
  	Stan Bauman, Immuno-Mycologics
 	Thomas Duesterberg, Hudson Institute
 	Steven Ferguson, Cook
 	John Jennings
 	Jeff Kimbell, MDMA
 	Glen Lamey, Washington Legal Foundation
 	Steven Levy, Threshold Technologies
 	David Link, EXPERTech Associates
 	Jeff Pierce, Citizens for a Sound Economy
 	Ben Reid, Ben Reid & Associates
 	David Shoultz, Varian & Associates
 	Thomas Thompson, Quest Medical, Inc.
 	Larry Pilot, McKenna & Cuneo

THURSDAY, MAY 11   4:30pm-10:00pm

 	"Regulatory and Legislative Reform Plan and
Progress"
 	"Congress and FDA: The Unique Relationship"
 	"Success on Capitol Hill in 1995"

FRIDAY, MAY 12   8:30am-6:00pm

  	"Regulatory Reform Summit"
 	"CDRH Accomplishments in '94 and a Plan for
the Future"
  	"Industry Overview"
 	"History of 1976 Amendments and The
Original Intent of 510(k) Exemption"
 	"If You Could Change the CDRH Today, What
Would You
Do?"
 	"Health Care Reform, Regulation, and
Innovation in the Medical Device Industry"
 	"The Reference List: What is it and Why Does
it Exist?"
 	"Capital Availability and Funding in the
Current FDA Environment"
 	"Tort Reform"
 	"Use and Selection of Consultants"
 	"Products Liability: How to Get it and What it
Costs"
 	Cocktail Reception

SATURDAY, MAY 13 - 9:00am-1:00pm
 	"Success on the Hill: What the MDMA and the
Coalition Have Been Doing"
 	"Update on FDA Oversight Hearings"
 	"The Coalition's Legislative and Regulatory
Reform of FDA/CDRH Concept"
 	Closing Remarks
 	Election of 1995 MDMA Board of Directors

RESERVATION
INFORMATION
To make reservations for the Annual
Membership Meeting and Regulatory Reform
Summit, please mail,

MEDICAL DEVICE MANUFACTURERS
ASSOCIATION
Attn: Marta Kennedy
QUEST Medical, Inc.
One Allentown Parkway / Allen, Texas 75002
Phone:	214-390-9800 ext 351 / Fax: 214-390-
2881

MDMA MEMBER: $250 NON MEMBER: $300
Payable by check, money order, or company
purchase order number.
To make hotel reservations, please contact:
RAMADA PLAZA HOTEL
Massachusetts & Vermont Avenues, N.W.
Washington, DC 20005
Phone: 202-842-1300         Fax: 202-371-9602

National Medical Device Coalition's
“BLUEPRINT FOR
REFORM”
The "Blueprint for Reform" began in Dallas, Texas
in early December, 1994, when representatives of 10
trade associations met to discuss one common goal:
FDA reform.  The National Medical Device
Coalition is working closely with House and Senate
leaders to make these reforms a reality.  This is the
most important opportunity for FDA reform since
the 1976 Amendments of the Food and Drug
Administration which started the medical device
approval process.

Time is of the essence! Never again will there be an
opportunity for our industry to gain control of its
future.

The final product is now ready and will be presented
at the MDMA Regulatory Reform Summit in
Washington, DC.

Even if you are unable to attend the MDMA
Regulatory Reform Summit, you can still pledge
your support by giving $100 or more to the National
Medical Device Coalition.  In addition to the
personal efforts of a number of the member
associations, we plan to spend “major bucks" for this
campaign and your commitment is critical.

Please mail your check payable to:

The National Medical Device Coalition
1575 Eye Street, N.W.
Suite 500
Washington, DC 20005

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 Commission on  of Immunohistochemical
Manufacturers

MDMA
MEDICAL DEVICE
MANUFACTURERS
ASSOCIATION

WASHINGTON OFFICE: 202-898-5700