30-day PMA supplement mechanism getting increased use at FDA, Burlington says.
This article was originally published in The Gray Sheet
30-DAY PMA SUPPLEMENTS WILL BE USED MORE OFTEN BY FDA as part of an effort to improve efficiency in the agency's PMA supplement program, Bruce Burlington, director of FDA's Center for Devices and Radiological Health, says in a May 18 letter to device manufacturers. "When applicable, FDA will provide guidance to" holders of premarket approval application "on the types of changes that can be reported in a 30-day supplement and the data required to support those changes."
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