ID:

367

Date:

2009-02-18

Headline:

FDA's Risky Gamble with the Safety of Medical Devices

Reporter's name:

Delay/denial:

No

Lawsuit:

No

Fees:

No

Media outlet:

Project On Government Oversight press release

City:

Washington, DC

Summary:

The Food and Drug Administration ceased ensuring medical devices manufacturers met long-standing safety requirements, according to records obtained by a watchdog group through FOIA. The Project On Government Oversight (POGO) discovered that FDA inspected device factories only once in 2008. As recently as 2005, the agency made 33 inspections. The Supreme Court ruled in 2008 that patients injured by medical devices cannot sue the manufacturers if the FDA has approved their use

Keywords:

FDA, medical device, regulation, inspection, investigation, POGO, manufacturer, safety

URL:

http://www.pogo.org/pogo-files/reports/public-health/safety-of-medical-devices/ph-fda-20090218.html

Agencies:

FDA

States:

DC

Categories:

business
health care
public health