Media Room

For More Information Contact

For Media Inquiries:

Dana Korsen

Mailing Address

The National Academies of Sciences, Engineering, and Medicine

Health and Medicine Division

500 Fifth St, NW
Washington, DC 20001

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    • Activity: Public Health Effectiveness of the FDA 510(k) Clearance Process [Remove]
    • Date: More than 2 Years [Remove]
    • Topic: Quality and Patient Safety [Remove]
    • Type: Media Advisory [Remove]

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The latest news from HMD, including information about new reports, activities, meetings, and other noteworthy events.

Media Advisory

IOM Report on FDA’s 510(k) Medical Device Clearance Process to be Released July 29
Released: 7/22/2011

Prompted by concerns that have been raised about whether the 510(k) clearance process is adequately protecting and promoting the public’s health, the FDA asked the IOM to convene a committee to evaluate the process and make recommendations aimed at protecting public health while preserving a mechanism to get new medical devices to market in a timely manner.

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