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Article: DEHP labeling or elimination urged in FDA guidance draft.
- Article from:
- Medical Device Daily
- Article date:
- September 10, 2002
CopyrightCOPYRIGHT 2002 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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DEHP labeling or elimination urged in FDA guidance draft
By DON LONG
Medical Device Daily Managing Editor
In a move that expresses a clearly increasing concern about the use of DEHP to make polyvinlylchloride (PVC) products for medical care, the FDA late Friday issued a draft guidance recommending labeling of devices to indicate their DEHP content and the additional recommendation to consider eliminating the use of DEHP in certain devices that can result in high aggregate exposures in sensitive patient populations.
In releasing the draft guidance for comment those comments to be accepted through Dec. 5 the agency noted animal studies ...