|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| NM1
|
|
|
| 09/29/2005
|
| FDA
|
| FDA
|
| 10/04/2005
|
| 57881-57883
|
|
|
| pdf
|
| Meeting on 11/17/05
|
|
|
| Signature:
|
| Jeffrey Shuren
|
|
|
|
|
| APE1
|
| 10/12/2005
|
| 10/12/2005
|
| Device Association
|
| Association
of Medical Device Reprocessors (AMDR)
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Naomi Joy Levan Halpern
|
|
|
|
|
| TR1
|
| 12/14/2005
|
| 12/14/2005
|
| Federal
Government
|
| Transcript of November
17, 2005 Meeting
|
|
|
|
|
|
|
| txt,
01, 02
|
|
|
|
|
|
|
|
|
| LST1
|
| 12/15/2005
|
| 12/15/2005
|
| Federal
Government
|
| Agenda for
November 17, 2005 Stakeholder Meeting
|
|
|
|
|
|
|
| doc
|
|
|
|
|
|
|
| TS1
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Medical
Device Manufacturers Association (MDMA)
|
|
|
|
|
|
|
| pdf,
ppt
|
| The User Fee Structure
|
|
|
| Signature:
|
| Mark Leahey
|
|
|
|
|
| TS2
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced
Medical Technology (AdvaMed), Cordis Corporation
|
|
|
|
|
|
|
| pdf,
ppt
|
| MDUFMA Stakeholders
Meeting - Performance Goals
|
|
|
| Signature:
|
| Marlene Valenti
|
|
|
|
|
| TS3
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
| Performance Goals
|
|
|
| Signature:
|
| Robert Britain
|
|
|
|
|
| TS4
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced Medical Technology
(AdvaMed)
|
|
|
|
|
|
|
| pdf,
ppt
|
| Qualitative Performance
Goals
|
|
|
| Signature:
|
| Patricia B Shrader
|
|
|
|
|
| TS5
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Robert Britain
|
|
|
|
|
| TS6
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced
Medical Technology Association (AdvaMed)
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Diane Wurzburger
|
|
|
|
|
| TS7
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Association of Medical
Device Reprocessors
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Naomi Halpern
|
|
|
|
|
| TS8
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Association of Medical
Device Reprocessors
|
|
|
|
|
|
|
| pdf,
ppt
|
| Reprocessing
of Single-Use Devices (SUD's)
|
|
|
| Signature:
|
| Tony Blank
|
|
|
|
|
|
|
|
| TS9
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Robert Britain
|
|
|
|
|
| TS10
|
| 12/15/2005
|
| 12/15/2005
|
| Device Industry
|
| National Venture Capital
Association (NVCA)
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Jack Lasersohn
|
|
|
|
|
| TS11
|
| 12/15/2005
|
| 12/15/2005
|
| Consumer Group
|
| National Research
Center for Women & Families
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
|
| Signature:
|
| Diana Zuckerman PhD
| |
|
|
|
| NM2
|
|
|
| 04/12/2006
|
| FDA
|
| FDA
|
| 04/13/2006
|
| 19192-19193
|
|
|
| htm
pdf
|
| Meeting on 5/22/06
|
|
|
| Signature:
|
| JEFFREY SHUREN
|
|
|
|
|
| TR2
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Transcript of the May 22, 2006 Meeting
|
|
|
|
|
|
|
| pdf
txt
|
|
|
|
|
|
|
|
|
| TS12
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Barnett Intro for MDUFMA
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Mark Barnett
|
|
|
|
|
| TS13
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Linda Kahan Opening Remarks for 05/22/2006 meeting
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Linda Kahan
|
|
|
|
|
| LST2
|
| 06/13/2006
|
| 06/13/2006
|
| Federal Government
|
| Agenda for May 22, 2006 Stakeholder Meeting
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| TS14
|
| 06/13/2006
|
| 06/13/2006
|
| Federal Government
|
| CDRH: MDFUMA Performance Update
|
|
|
|
|
|
|
| pdf
ppt
|
|
|
|
|
|
| Signature:
|
| Donna-Bea Tillman, PhD
|
|
|
|
|
| TS15
|
| 06/13/2006
|
| 06/13/2006
|
| Association
|
| National Venture Capital Association
|
|
|
|
|
|
|
| pdf
ppt
|
| FDA Stakeholder Meeting On Implementation of MDUFMA Review Performance Goals
|
|
|
| Signature:
|
| David Douglass
|
|
|
|
|
|
|
|
|
