Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns

摘要

Many device manufacturers aren't doing a good job of capturing and analyzing product quality data - a misstep that could lead to FDA regulatory action, agency officials say. "I'm sure most firms would say they have their quality data sources clearly identified. I'm going to tell you that across the board, I don't think so," said Phil Pontikos, FDA's national expert on medical devices.