FDA AUTOMATIC EXTERNAL DEFIBRILLATOR DESIGN, GMP CONCERNS
This article was originally published in The Gray Sheet
Executive SummaryFDA AUTOMATIC EXTERNAL DEFIBRILLATOR DESIGN, GMP CONCERNS will be raised by the agency at a Sept. 23 closed meeting with invited manufacturers, agency staffers says. FDA feels that manufacturers have not met the agency's expectations regarding defibrillator design and good manufacturing practices.
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