FDA > CDRH > Strategic Plan > Roster List of Six CDRH Product Area - User Fee Program Review Teams

Roster List of Six CDRH Product Area - User Fee Program Review Teams

CDRH has chartered six product area groups to help us implement MDUFMA with TLPC principles. These groups are chaired by the ODE Division Directors and the Director of OIVD, with representatives of Offices across the Center. They recently were asked for progress reports on the MDUFMA hiring and other implementation issues.

As the groups work on the MDUFMA hires, Dr. Feigal the groups to address the following tasks:

Assess what they have been able to accomplish with hiring in FY03;

Consider what unmet needs they have for FY04, reassess the FY04 priorities they have already developed, and re-do the if necessary;

Consider additional needs for contracts, external experts and operating dollars for FY04.
 

Cardiovascular Devices

Chair: Donna-Bea Tillman

Members: Kay Barrick, John Glass, Gerry Gray, Larry Grossman, Steve Hilbert, David Kalins, Pat Kingsley, Tom Gross, Subhas Malghan, Don Serra, Margaret Tolbert
 

General, Restorative and Neurological Devices

Chair: Celia Witten

Members: Miriam Provost, Mark Melkerson, Tom Gross, Pat Kingsley, Kay Barrick, Mary Hanna, Victor Krauthamer, Domini Cassis, Gladys Rodriguez, Steve Hilbert, Carol Fedorchak, Betty Collins, Al Thomas, Mike Marcarelli
 

Ophthalmic and Ear, Nose and Throat Devices

Chair: Ralph Rosenthal

Members: Betty Collins, Ron Swann, Kay Barrick, Gerry Gray, Tom Gross, Bob James, Joe Hutter, Paula Silberberg, Mary Hanna, Joe Puleo, Dave Whipple
 

Reproductive, Abdominal, and Radiological Devices

Chair: Nancy Brogdon

Members: Betty Collins, Gladys Rodriguez, Tom Gross (Pat Kingsley alternate), Greg Campbell, Margaret Tolbert, Dave Segerson, Bob James, Howard Cyr (Larry Cress, alternate), Kyle Myers (Bob Gagne, alternate till 2/24), Joe Hutter
 

Anesthesiology, General Hospital, Infection Control, and Dental Devices

Chair: Susan Runner

Members: Kay Barrick, Kathy Merritt, Pat Kingsley, Mel Stratmeyer, Harry Sauberman, Tom Gross, Pat Kingsley, Betty Collins, Gladys Rodriguez, Arthur Yellin, Margaret Tolbert
 

In Vitro Diagnostics

Chair: Steve Gutman

Members: Don St. Pierre, Joe Hackett, Greg Campbell, Tom Gross, Marilyn Lightfoote, David Brown, Cornelia Rooks

Updated February 11, 2004