Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance

• Guidance for medical gloves
• Import and export
• Import/export regulatory requirements for medical devices
• Investigational device exemptions
• Investigational device exemptions manual
• Labeling
• Medical device GMP guidance for FDA investigators
• Medical device, Federal register documents, February 13, 1976 to October 26, 1989
• Need help with medical device regulations?
• Premarket notification, 510(k)
• Regulatory requirements for medical devices
• The Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992