US FDA/CDRH: Industry Support - Assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Assistance for small manufacturers and other domestic and foreign producers of medical devices and radiation-emitting electronic products

Key Topics
• Medical Device Recalls

Services Provided to Industry
• Answer Questions
• Workshops
• Premarket Notification [510(k)] Status Request Program
• Teleconferences

How to Contact Us
• General Information
• Comments

Resources
• Device Advice
• Ombudsman
• FDA and Centers for Medicare & Medicaid Services
• US Small Business Administration
• Directory of State and Local Officials

CDRH Initiatives
• Third Party
• International
• US/EU Mutual Recognition Agreement
• FDA Human Factors Program
• Invitation to Manufacturers of Infusion Pumps

Documents
• CDRH Guidance Documents
• Manuals
• Small Business Guide to FDA
• Annual reports
• Frequently Used CDRH web pages
• Brochures
• Regulations

Office of Communication, Education, and Radiation Programs (OCER)
• What we do
• Divisions

Updated June 2, 2006

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Center for Devices and Radiological Health / CDRH