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Medical Devices
Device Advice: Comprehensive Regulatory Assistance
Overview of Medical Device Regulation
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Section Contents Menu
Device Advice: Comprehensive Regulatory Assistance
Overview of Medical Device Regulation
Medical Device Provisions of FDA Modernization Act
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Medical Device Provisions of FDA Modernization Act
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About the FDA Modernization Act
Overview of FDA Modernization Act of 1997, Medical Device Provisions
Full Text of FDAMA law
Food and Drug Administration Modernization Act (FDAMA) of 1997 (PDF Version)
(PDF - 399KB)
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Documents
Guidance Pertaining to the FDA Modernization Act of 1997
Federal Register Notices Pertaining to the FDA Modernization Act of 1997
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Other Resources
Food and Drug Administration Modernization Act (FDAMA) of 1997
The Food and Drug Law Institute
Advanced Medical Technology Association
Association for the Advancement of Medical Instrumentation
The Association of Electrical and Medical Imaging Equipment Manufacturers
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Related Activities
Third Party Review
The Least Burdensome Provisions - Activities Related to Implementation
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