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News and Announcements

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

News Release

FDA Should Invest in Developing A New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process
Released: 7/29/2011

The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the IOM.

Report at a Glance

  • Accompanying Letter to the FDA (PDF)
  • Press Release (HTML)
  • Report Brief (PDF, HTML)
  • Senate Testimony (PDF)
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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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