GAO Publishes Report on FDA's Premarket Review and Postmarket Safety Efforts

The U.S. Government Accountability Office has released a report outlining its review of the U.S. Food and Drug Administration's approval processes for medical devices.

The FDA is responsible for reviewing medical devices via either the 510(k) premarket notification process or the more stringent premarket approval process. The FDA also has broad responsibilities for postmarket surveillance of devices, including oversight of recalls.

GAO's report on the FDA's approval processes showed the FDA has begun to take steps to address GAO's previous 2009 recommendations about its approval of high-risk devices, but "progress has been limited." In 2009, GAO recommended FDA issue regulations for high-risk devices that are currently allowed to enter the market through the 510(k) process. Since then, the FDA has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA has not issued regulations for the 26 remaining types of high-risk devices.

This means some categories of high-risk devices, such as automated external defibrillators and implantable hip joints, can still enter the U.S. market through the less stringent 510(k) process. Among other shortcomings, GAO also reported the FDA has not been routinely analyzing recall data, which can help determine any trends in recalls over time.

Read the full GAO report on the FDA's approval processes for medical devices.

Read other coverage about medical devices:

- Device Makers' Confidentiality Will Raise Costs, AHRMM Says

MDMA: GPOs Should Be Included in "Sunshine" Provisions

Supply Chain Execs Increase Focus on Health IT and Patient Safety

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