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How does the Medical Device Provisions of FDA Modernization Act apply to imports of medical devices?
Congress amended the FFD&C Act in an effort to streamline the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. With respect to medical devices, the FDA is directed to focus its resources on the regulation of those devices that pose the greatest risk to the public and those that offer the most significant benefits. The FDA must base its decisions on clearly defined criteria and provide for appropriate interaction with the regulated industry. The new legislation assumes that enhanced collaboration between the FDA and regulated industry will accelerate the introduction of safe and effective devices to the U.S. The Modernization Act was signed into law by President Clinton on November 21, 1997. Most provisions went into effect on February 19, 1998 (90 days from enactment of the Modernization Act), while some have different effective dates or require implementing regulations. This document presents a summary of each device related section of the Modernization Act, combined under relevant headings, i.e. IDE
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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