FDA to Review Medical Devices Marketed Prior to 1976

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA to Review Medical Devices Marketed Prior to 1976

FDA to Review Medical Devices Marketed Prior to 1976
Wed, 08 Apr 2009 10:24:00 -0500

The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

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