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:
Consumer Staff Telephone Numbers:
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. |
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.
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 |
Ext. | Name |
---|---|
139 | Alderton, Bonnie |
109 | Benson, Cynthia |
144 | Stellar, Barbara |
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 |
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 |
Ext. | Name |
---|---|
113 | Watts, Crystal |
Ext. | Name |
---|---|
127 | Daly, Connie |
122 | Clark, Geoff |
111 | Perez, Rod |
112 | Tartal, Joe |
118 | Taylor, Tawana |
Ext. | Name |
---|---|
124 | Stigi, John |
Ext. | Name |
---|---|
117 | Pak, Yung |
Ext. | Name |
---|---|
139 | Alderton, Bonnie |
109 | Benson, Cynthia |
144 | Stellar, Barbara |
Ext. | Name |
---|---|
116 | Puleo, Joe |
Ext. | Name |
---|---|
123 | Raines, Joyce |
118 | Taylor, Tawana |
113 | Watts, Crystal |
Ext. | Name |
---|---|
128 | Carey, Carole |
125 | Sutton, Bill |
Ext. | Name |
---|---|
114 | Allen, Gene |
Ext. | Name |
---|---|
123 | Raines, Joyce |
Ext. | Name |
---|---|
112 | Tartal, Joe |
Ext. | Name |
---|---|
116 | Puleo, Joe |
112 | Tartal, Joe |
Ext. | Name |
---|---|
128 | Carey, Carole |
123 | Raines, Joyce |
124 | Stigi, John |
125 | Sutton, Bill |
118 | Taylor, Tawana |
113 | Watts, Crystal |
Ext. | Name |
---|---|
117 | Pak, Yung |
111 | Perez, Rod |
Ext. | Name |
---|---|
117 | Pak, Yung |
Ext. | Name |
---|---|
116 | Puleo, Joe |
124 | Stigi, John |
125 | Sutton, Bill |
Ext. | Name |
---|---|
117 | Pak, Yung |
111 | Perez, Rod |
Ext. | Name |
---|---|
114 | Allen, Gene |
Ext. | Name |
---|---|
116 | Puleo, Joe |
112 | Tartal, Joe |
Ext. | Name |
---|---|
122 | Clark, Geoff |
123 | Raines, Joyce |
118 | Taylor, Tawana |
Ext. | Name |
---|---|
126 | Rodriquez, Geisha |
Ext. | Name |
---|---|
114 | Allen, Gene |
127 | Daly, Connie |
121 | Garris, Cindy |
Ext. | Name |
---|---|
125 | Sutton, William |
Ext. | Name |
---|---|
124 | Stigi, John |
125 | Sutton, Bill |
Updated February 21, 2008
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