Resources for Food and Drug Administration (FDA)

FDA Faulted for Scrutiny Of Medical-Device Makers

online.wsj.com

The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign facilities, according to congressional investigators.

In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.

View the Resource

Share or bookmarklet this web page at: