The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.
“The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade. Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday.”
“The FDA may have gone too far and violated federal law when it chose to monitor 6 scientists who made public their safety concerns about medical devices approved at the agency, a congressional investigation has concluded.”
Seattle Times series on marketing of orphan drugs for off label use
ISSUE: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall.
FDA has created a new form for consumers to report adverse events with drugs or devices. This less technical form is part of larger FDA effort to encourage consumers to submit quality reports.
Washington Post reports: “The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.”
The FDA is granting money to Glaxcosmithkline – up to $200 million in 5 years- to help develop medication that can work against antibiotic resistant superbugs. Glaxcosmithkline has paid the largest health care fraud settlement in US history-$3 billion.