Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

Jane Akre
February 13, 2012

A must watch show

How to Watch: Go to (link will show up when gavel begins hearing, live feed)

Hearing: "Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients"

When: The Subcommittee on Health has scheduled a hearing on Wednesday, February 15, 2012, at 10:00 a.m. in room 2322 of the Rayburn House Office Building.

Hearing Notice

Background Memo

What It's About:

Basically how will patient safety fare in the new FDA budget for device reviews? It's Congress that decides on the budget in cooperation with the medical device industry, which would like a favorable outcome - less regulation, more jobs, more profits. On February 15, the Health sub-committee of the House Energy and Commerce Committee will call Dr. Jeffrey Shuren who oversees medical devices at the Center for Devices & Radiological Health as a witness.

The panel is led by Rep. Joe Pitts (R-PA). He is on record as saying:

We need the FDA to make sure that devices are safe, but we don’t need them to stand in the way of cures or jobs,” Pitts wrote in a November, 2011 editorial in the Philadelphia Inquirer.

Call to Action:

Rep. Pitts Washington, D.C. office, (202) 225-2411

Rep. Cliff Stearns Washington, D.C. office (202) 225-5744

Rep. Fred Upton Washington, D.C. office (202) 225-3761

Public Citizen has a way for you to tell Congress to strengthen the FDA’s medical device approval process for implanted devices to be as strong as the approval process for drugs. Here is the Public Citizen Call for Action:

Witness List (Updated with Statements)*

Panel 1

Dr. Jeffrey Shuren


Center for Devices and Radiological Health (CDRH)

Food and Drug Administration (FDA)

Witness Testimony (Truth in Testimony)

Panel 2

David Perez

President and Chief Executive Officer

Terumo BCT

Witness Testimony (Truth in Testimony)

Elisabeth M. George

Vice President, Global Government Affairs, Regulations and Standards

Philips Healthcare

Witness Testimony (Truth in Testimony)

Ralph Hall, J.D.

Distinguished Professor and Practitioner

University of Minnesota Law School

Witness Statement (Truth in Testimony)

Ross Jaffe, M.D.

Managing Director

Versant Ventures

Witness Statement (Truth in Testimony)

Aaron S. Kesselheim, M.D., J.D., M.P.H.

Assistant Professor of Medicine at Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women's Hospital

Witness Testimony (Truth in Testimony)

Art Sedrakyan, M.D., Ph.D.

Associate Professor

Director, Patient-Centered Comparative Effectiveness Program

Weill Cornell Medical College and New York Presbyterian Hospital

Witness Testimony (Truth in Testimony)

Lisa Swirsky

Senior Policy Analyst

Consumers Union

Witness Testimony (Truth in Testimony)

Mr. Jim Shull

Browns Mills, NJ

Here is his Patient Profile on Mesh Medical Device News Desk


February 13, 2012

To: Energy and Commerce Committee Members

From: Majority Staff

Re: Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients


The federal regulatory regime for medical devices has three levels of classification. FDA classifies a device based on its intended use and the level of oversight needed to provide a reasonable assurance of safety and effectiveness. These classifications are Class I, Class II and Class III. Class III devices receive the highest level of oversight while Class I devices the least. Examples of Class I devices include elastic bandages and examination gloves. Powered wheelchairs and most imaging devices are Class II devices. Coronary stents and heart valves are examples of Class III devices.

The federal regime also sets forth the 510(k) clearance process and premarket approval application (PMA) process for the marketing of medical devices. FDA generally uses the 510(k) process to clear Class II devices and PMA process to approve Class III devices.

Congress first authorized a medical device user fee in 2002 and last reauthorized the fee as part of the Medical Device User Fee Amendments of 2007 (MDUFA). Under this user fee authority, FDA collected $287 million from Fiscal Year 2008 to Fiscal Year 2012. The statute authorizes FDA to collect these funds through three types of medical device user fees. These include application fees, establishment fees and product fees.2 Without Congressional action, FDA’s ability to collect user fees under MDUFA will end in September 2012, and FDA will have to lay off employees.

2 For Fiscal Year 2012, the fee rates are the following: application fees ($220,050 for PMAs and $4,049 for 510(k)s), establishment fees ($2,029), and product fees ($7,702 for Class III devices)).

The Committee did not receive the proposed medical device user fee agreement by January 15, 2012, as required under law, but FDA did announce in early February that an agreement had been reached with industry. The Committee will not receive the proposed agreement until the completion of certain statutory steps, including a 30-day public notice and comment period. While still unofficial, it is expected that the proposed agreement will provide Majority Memorandum for the February 15, 2012, Health Subcommittee Hearing for $595 million in user fees for Fiscal Years 2013-2017, and greater predictability, consistency and transparency in the premarket review process.


Should you have any questions regarding the hearing, please contact Clay Alspach or Ryan Long at (202) 225-2927.

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