FDA warns companies over pre-amendments devices

08/17/2009 | Medical Devices Today

The FDA's Center for Devices and Radiological Health is receiving submissions of safety and effectiveness data for 25 types of medical devices that are classified as pre-amendments products. The agency plans to review the documents and then publish them online, an agency spokeswoman said. The FDA's device unit could file an injunction or take other legal actions if the companies fail to submit the necessary documents.

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