DSMICA - Contact Us

You may contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at CDRH via email, telephone or fax.

Email:  dsmica@fda.hhs.gov or industry.devices@fda.hhs.gov

Telephone:  1-800-638-2041 or 301-796-7100

Follow the prompts:

• For Consumer Questions - press 1
• For Industry Questions - press 2 

Fax:  301-847-8149 

DSMICA can assist you with questions on a variety of topics including the following:

• 510(k) - Status of Submission
• 510(k) - Premarket Notification
• Adverse Events Reporting including Medical Device Reporting (MDR)
• Accredited Persons/Third Party Review and Third Party Inspection
• Biocompatibility
• Bioresearch Monitoring Program (BIMO)
• Classification of Medical Devices
• Consumer Assistance
• Corrections and Removals
• Design Controls/Pre-production Quality Assurance
• Electronic Products Radiation Control
• Establishment Registration / Medical Device Listing
• Export Requirements
• Global Harmonization Activities
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Guidance Documents and Publications
• Good Manufacturing Practices (GMP) / Quality Systems
• Harmonization By Doing (HBD)
• Import Requirements
• In Vitro Diagnostic (IVD) Products
• Inspections of Medical Device Establishments
• Investigational Device Exemption (IDE)
• Labeling
• Premarket Approval (PMA)
• Postmarket Studies
• Quality Systems/Good Manufacturing Practices (GMP)
• Recalls
• Regulations
• Regulatory Requirements to Market a Medical Device
• Reprocessing of Single Use and Multiple Use Devices
• Risk Communications
• Small Business Determinations (SBDs)
• Standards
• Summary Technical Documentation (STED)
• Tracked Devices
• User Fees