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FDA > CDRH > Device Advice > DSMICA Staff Directory

DSMICA Staff Directory

Telephone

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) has an automated telephone system. Please listen to the voice prompts before pressing any numbers on your telephone keypad.

Manufacturers Assistance and International Staff Telephone Numbers:

  • 800-638-2041 or
  • 240-276-3150 (Please note new phone number)

Consumer Staff Telephone Numbers:

  • 240-276-3103 (Please note new phone number) or
  • 888-INFO-FDA (888-463-6332) - FDA's toll free number
    Follow the voice prompts (that is 2,1,4,1) to the Center for Medical Devices and Radiological Health's Consumer Assistance staff.

Please Note: If you experience a long time on hold, you may fax your questions to 240-276-3151 or email us at dsmica@cdrh.fda.gov and we will respond as quickly as possible.

Staff Directory

You may contact a DSMICA employee directly with specific questions. All DSMICA employees can be reached by entering their three digit extension number at any time during the telephone greeting. Below is a list of DSMICA employees, their extensions and area of expertise; however, most DSMICA employees can assist you in all medical device related areas.


Manufacturers Assistance Staff
Ext. Name Expertise
114 Allen, Gene Publications, Small Business Determinations
128 Carey, Carole International Affairs, Global Harmonization, HBD (Harmonization By Doing), PMA, IDE, Cardiovascular, EMC (electromagnetic compatibility), standards.
122 Clark, Geoffrey 510(k), Regulations/General
127 Daly, Connie Small Business Determinations, 510(k)
121 Garris, Cindy Small Business Determinations
117 Pak, Yung PMA, IDE, Labeling, Biocompatibility
111 Perez, Rod PMA, IDE, 510(k)
116 Puleo, Joe Management, Design Controls, GMP, Inspections
123 Raines, Joyce Registration/Listing, Regulations/General, International Affairs, Asia
126 Rodriquez, Geisha Secretary
124 Stigi, John Management, Accredited Persons/Third Party, US/EC MRA
125 Sutton, Bill Management, International Affairs, US/EC MRA, Europe, GHTF
112 Tartal, Joe Quality System/GMP, IVD, 510(k)
118 Taylor, Tawana Regulations/General, Registration/Listing, Americas (Canada, Mexico)
113 Watts, Crystal Registration/Listing, 510(k) status/Middle East/Russia

Consumer Staff  
Ext. Name
139 Alderton, Bonnie
109 Benson, Cynthia
144 Stellar, Barbara

International Staff
Ext. Name Expertise
128 Carey, Carole Global Harmonization, Harmonization By Doing
123 Raines, Joyce Asia*
124 Stigi, John US/EC MRA
125 Sutton, Bill Europe*
118 Taylor, Tawana Americas (Canada, Mexico*)
113 Watts, Crystal Middle East/Russia
* Designated Desk Officer handling inquiries from countries listed.

Expertise Legend
510(k) = Premarket Notification 510(k)
510(k) Status = Status of 510(k) Submission
Design Controls = Preproduction Quality Assurance/Design Controls
GGP = Good Guidance Practices
GHTF = Global Harmonization Task Force
IDE = Investigational Device Exemptions
IVD = In Vitro Diagnostic Products
PMA = Premarket Approval
QS/GMP = Quality Systems/Good Manufacturing Practices
US/EC MRA = United States/European Community Mutual Recognition Agreement

Areas of Expertise
510(k) - Status of Submission
510(k) - Premarket Notification
Accredited Persons/Third Party Review
Biocompatibility
Consumer Assistance
Design Controls/Preproduction Quality Assurance
Establishment Registration / Device Listing
Global Harmonization Task Force
Guidance Document Coordinator
Good Manufacturing Practices (GMP) / Quality Systems
Import/Export
In Vitro Diagnostic Products
Inspections
International Affairs
Investigational Device Exemption (IDE)
Labeling
Management
Premarket Approval (PMA)
Premarket Notification [510(k)]
Publications
Quality Systems/Good Manufacturing Practices (GMP)
Regulations/General
Rubber Products
Secretary
Small Business Certification
Third Party Program
US/EC Mutual Recognition Agreement

Expertise List

510(k) - Status of Submission
Ext. Name
113 Watts, Crystal
Return to: Expertise Legend

Premarket Notification 510(k)
Ext. Name
127 Daly, Connie
122 Clark, Geoff
111 Perez, Rod
112 Tartal, Joe
118 Taylor, Tawana
Return to: Expertise Legend

Accredited Persons/Third-Party
Ext. Name
124 Stigi, John
Return to: Expertise Legend

Biocompatibility
Ext. Name
117 Pak, Yung
Return to: Expertise Legend

Consumer Assistance
Ext. Name
139 Alderton, Bonnie
109 Benson, Cynthia
144 Stellar, Barbara
Return to: Expertise Legend

Design Controls/Preproduction Quality Assurance
Ext. Name
116 Puleo, Joe
Return to: Expertise Legend

Establishment Registration/Device Listing
Ext. Name
123 Raines, Joyce
118 Taylor, Tawana
113 Watts, Crystal
Return to: Expertise Legend

Global Harmonization Task Force (GHTF)
Ext. Name
128 Carey, Carole
125 Sutton, Bill
Return to: Expertise Legend

Guidance Document Coordinator
Ext. Name
114 Allen, Gene
Return to: Expertise Legend

Import/Export
Ext. Name
123 Raines, Joyce
Return to: Expertise Legend

In Vitro Diagnostic Products
Ext. Name
112 Tartal, Joe
Return to: Expertise Legend

Inspections/QSIT
Ext. Name
116 Puleo, Joe
112 Tartal, Joe
Return to: Expertise Legend

International Affairs
Ext. Name
128 Carey, Carole
123 Raines, Joyce
124 Stigi, John
125 Sutton, Bill
118 Taylor, Tawana
113 Watts, Crystal
Return to: Expertise Legend

Investigational Device Exemption (IDE)
Ext. Name
117 Pak, Yung
111 Perez, Rod
Return to: Expertise Legend

Labeling
Ext. Name
117 Pak, Yung
Return to: Expertise Legend

Management
Ext. Name
116 Puleo, Joe
124 Stigi, John
125 Sutton, Bill
Return to: Expertise Legend

Premarket Approval (PMA)
Ext. Name
117 Pak, Yung
111 Perez, Rod
Return to: Expertise Legend

Publications
Ext. Name
114 Allen, Gene
Return to: Expertise Legend

Quality Systems/GMP
Ext. Name
116 Puleo, Joe
112 Tartal, Joe
Return to: Expertise Legend


Regulations/General
Ext. Name
122 Clark, Geoff
123 Raines, Joyce
118 Taylor, Tawana
Return to: Expertise Legend

Secretary
Ext. Name
126 Rodriquez, Geisha
Return to: Expertise Legend

Small Business Certification
Ext. Name
114 Allen, Gene
127 Daly, Connie
121 Garris, Cindy
Return to: Expertise Legend

Third Party Program
Ext. Name
125 Sutton, William
Return to: Expertise Legend

US/EC Mutual Recognition Agreement
Ext. Name
124 Stigi, John
125 Sutton, Bill
Return to: Expertise Legend

Updated February 21, 2008

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