From owner-diagnostics@net.bio.net Sat May 13 23:00:00 1995 Path: biosci!bloom-beacon.mit.edu!gatech!howland.reston.ans.net!nntp.crl.com!decwrl!svc.portal.com!news1.best.com!usenet From: "B.B." Newsgroups: bionet.diagnostics Subject: SUPPORT FDA REFORM FOR IN VITRO DIAGS. READ THIS >> Date: 14 May 1995 01:23:49 GMT Organization: BEST Internet (415) 964-2378 Lines: 200 Message-ID: <3p3m35$e6k@news1.best.com> NNTP-Posting-Host: biotech.vip.best.com ON MAY 11, 1995 THE BLUE PRINT FOR FDA REFORM WILL BE INTRODUCED 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 .