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Institute of MedicinePublic Health Effectiveness of the FDA 510(k) Clearance Process

The report has been released Friday 29 July 2011..

Medical devices play a critical role in the health care of Americans. They can range from simple tools, such as tongue depressors and bandages, to complexer life-saving equipment, such as pacemakers, magnetic resonance imaging machines, and heart–lung machines. Devices are used in healthcare facilities—such as hospitals, physicians’ offices, and nursing homes—and at home.

The Federal Food, Drug, and Cosmetic Act

(FFDCA) requires a “reason-able assurance of safety and effectiveness” before a device can be marketed.The U.S. Food and Drug Administration (FDA) is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patientsgenerally cannot go on the market until they are cleared through the 510(k)process, named for Section 510(k) of the FFDCA. Devices that are subject tothe 510(k) process include such devices as blood pressure cuffs as well as some types of contact lenses and pacemakers. The FDA received about 4,000 510(k)submissions in 2009.Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-deviceindustry, have asserted that the process has become too burdensome andtime-consuming and that it is delaying important new medical devices from entering the market.The FDA turned to the Institute of Medicine (IOM), which appointed acommittee to review the 510(k) process:

The video briefing – 1 hour – is found here on the IOM site


Here is the Letter from the IOM to the FDA

Here is the Overview Report:

And here is the Full Report:

Have fun reading!