FDA overhauls approval process as medical devices come under fire

"The FDA regulates more than 190,000 different devices," Commissioner Dr. Scott Gottlieb notes.

(CNN)As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit newsroom is reporting more than 80,000 deaths potentially linked to medical implants since 2008.

Despite the timing, the FDA denies any connection between its communications and the report from the International Consortium of Investigative Journalists.
"We didn't even know about what the ICIJ was doing until early October," FDA spokeswoman Deborah Kotz said Tuesday. She added that the agency issued its Medical Device Safety Action Plan in April, laying out what it has done and what new steps it plans to take to enhance device safety.
"These actions are things that we've been working on for quite a while," Kotz said.
    Still, the concurrent release of information from the government regulator and the investigative team highlights the many challenges and missteps related to patient safety.