Is the Food and Drug Administration properly overseeing the approval and manufacturing of medical devices? This is the question brought by a House Energy and Commerce subcommittee who is seeking legislation to increase oversight of the FDA.

The Congressional subcommittee claims that the FDA has serious deficiencies in their reviewing processes, substandard postmarket surveillance, and that they irregularly inspected manufacturing facilities.

Their basic solution is this—allow consumers to file lawsuits against manufacturers of defective medical devices directly instead of just filing incidences with the FDA. This would prevent companies from being able to hide behind inadequate FDA standards for the products, thus ensuring safer devices.

This entry was posted on Monday, July 6th, 2009 at 5:48 pm and is filed under Medical Device, Safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.