GAO review finds fault in FDA’s device oversight

Jun. 18th, 2009 by Pia Christensen
Filed under: Government, Pharmaceuticals 

The Government Accountability Office looked into how the FDA oversees medical devices and found that it does not review all class III devices (those with greatest risk, such as pacemakers) through its most stringent process.

It also found problems with the FDA’s postmarket surveillance of medical devices, reporting that the agency says it cannot review all of the reports it receives. The FDA also has not conducted all of the required inspections of manufacturing plants in the United States and overseas.

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Comments

2 Comments on GAO review finds fault in FDA’s device oversight

  1. Obama trying to seize the moment on health care reform — MedCity Morning Read, June 19, 2009 : MedCity News on Fri, 19th Jun 2009 8:27 am

    2. [...] Government Accounting Office review finds fault in FDA’s device oversight (Covering Health blog) [...]

  2. Bill R. on Mon, 6th Jul 2009 1:12 pm

    3. I’m hopeful that the FDA gets their act together. It’s upsetting and disappointing to hear of established stands not being adhered to. Furthermore, I would think that domestic medical device manufacturers would welcome increased scrutiny to dispel any appearance of substandard workmanship in the products in question.

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