Medical Devices
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.
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Manufacturers Assistance and International Staff Telephone Numbers:
Consumer Staff Telephone Numbers:
Please Note: If you experience a long time on hold, you may fax your questions to 301-847-8149 or email us at dsmica@fda.hhs.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, alphabetical list
- Consumer Staff, alphabetical list
- International Staff, alphabetical list
- Expertise Legend
- Locate Employees by Area(s) of Expertise
Manufacturers Assistance Staff
| Name | Expertise |
|---|---|
| Allen, Gene | Publications, Small Business Determinations |
| Carey, Carole | International Affairs, Global Harmonization, HBD (Harmonization By Doing), PMA, IDE, Cardiovascular, EMC (electromagnetic compatibility), standards. |
| Clark, Geoffrey | 510(k), Regulations/General |
| Daly, Connie | Small Business Determinations, 510(k) |
| Ellsworth, Eva | Quality System / GMP |
| Garris, Cindy | Small Business Determinations |
| Pak, Yung | PMA, IDE, Labeling, Biocompatibility |
| Perez, Rod | PMA, IDE, 510(k) |
| Raines, Joyce | Registration/Listing, Regulations/General, International Affairs |
| Rodriquez, Geisha | Secretary |
| Snesko, Walter | Electronic Products Radiation Control |
| Stigi, John | Management, Accredited Persons/Third Party, US/EC MRA |
| Sutton, Bill | Management, International Affairs, GHTF |
| Tang, Xiaoqiu | International Affairs, Asia |
| Tartal, Joe | Management, Quality System/GMP, IVD, 510(k) |
| Taylor, Tawana | Regulations/General, Registration/Listing, Americas (Canada, Mexico) |
| Thompson, Crystal | Registration/Listing, 510(k) status/Europe |
| Velez Cabassa, Aileen | 510(k), Regulations/General, International Affaris (Latin America) |
| Name |
|---|
| Benson, Cynthia |
| Name | Expertise |
|---|---|
| Carey, Carole | Global Harmonization, Harmonization By Doing |
| Taylor, Tawana | Americas (Canada, Mexico*) |
| Thompson, Crystal | Europe |
* 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 |
Expertise List
| Name |
|---|
| Thompson, Crystal |
Return to: Expertise Legend
Premarket Notification 510(k)
| Name |
|---|
| Daly, Connie |
| Clark, Geoff |
| Perez, Rod |
| Tartal, Joe |
| Taylor, Tawana |
Return to: Expertise Legend
Accredited Persons/Third-Party
| Name |
|---|
| Stigi, John |
Return to: Expertise Legend
Biocompatibility
| Name |
|---|
| Pak, Yung |
Return to: Expertise Legend
Consumer Assistance
| Name |
|---|
| Alderton, Bonnie |
| Benson, Cynthia |
Return to: Expertise Legend
Design Controls/Preproduction Quality Assurance
| Name |
|---|
| Ellsworth, Eva |
| Tartal, Joe |
Return to: Expertise Legend
Electronic Products Radiation Control
| Name |
|---|
| Snesko, Walter |
Return to: Expertise Legend
Establishment Registration/Device Listing
| Name |
|---|
| Clark, Geoff |
| Raines, Joyce |
| Taylor, Tawana |
| Thompson, Crystal |
Return to: Expertise Legend
Global Harmonization Task Force (GHTF)
| Name |
|---|
| Carey, Carole |
| Sutton, Bill |
Return to: Expertise Legend
Guidance Document Coordinator
| Name |
|---|
| Allen, Gene |
Return to: Expertise Legend
Import/Export
| Name |
|---|
| Clark, Geoff |
| Raines, Joyce |
Return to: Expertise Legend
In Vitro Diagnostic Products
| Name |
|---|
| Ellsworth, Eva |
| Tartal, Joe |
Return to: Expertise Legend
Inspections/QSIT
| Name |
|---|
| Tartal, Joe |
Return to: Expertise Legend
International Affairs
| Name |
|---|
| Carey, Carole |
| Raines, Joyce |
| Stigi, John |
| Sutton, Bill |
| Tang, Xiaqiu |
| Taylor, Tawana |
| Thompson, Crystal |
| Velez Cabassa, Aileen |
Return to: Expertise Legend
Investigational Device Exemption (IDE)
| Name |
|---|
| Pak, Yung |
| Perez, Rod |
Return to: Expertise Legend
Labeling
| Name |
|---|
| Clark, Geoff |
| Pak, Yung |
| Tartal, Joe |
Return to: Expertise Legend
Management
| Name |
|---|
| Stigi, John |
| Sutton, Bill |
| Tartal, Joe |
Return to: Expertise Legend
Premarket Approval (PMA)
| Name |
|---|
| Pak, Yung |
| Perez, Rod |
Return to: Expertise Legend
Publications
| Name |
|---|
| Allen, Gene |
Return to: Expertise Legend
Quality Systems/GMP
| Name |
|---|
| Ellsworth, Eva |
| Pak, Yung |
| Tartal, Joe |
Return to: Expertise Legend
Regulations/General
| Name |
|---|
| Clark, Geoff |
| Raines, Joyce |
| Tartal, Joe |
| Taylor, Tawana |
| Velez Cabassa, Aileen |
Return to: Expertise Legend
Secretary
| Name |
|---|
| Rodriquez, Geisha |
Return to: Expertise Legend
Small Business Certification
| Name |
|---|
| Alderton, Bonnie |
| Allen, Gene |
| Daly, Connie |
| Garris, Cindy |
Return to: Expertise Legend
Third Party Program
| Name |
|---|
| Sutton, William |
Return to: Expertise Legend
US/EC Mutual Recognition Agreement
| Name |
|---|
| Stigi, John |
| Sutton, Bill |
Return to: Expertise Legend