Center for Devices and Radiological Health, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Institute of Medicine, Medical device, New England Journal of Medicine, New Medical Devices: Invention Development and Use (Series on Technology and Social Priorities), UNited States
Institute of Medicine – Public 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.
(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!
- 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
- Report could sway FDA device review process (earlsview.com)
- Barry Meier – Study Faults Approval Process for Medical Devices (earlsview.com)
- Report: IOM review of the FDA 510(k) process due Friday (earlsview.com)
- FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process (earlsview.com)
- IOM’s 510(k) assessment says FDA should abandon the entire process (medcitynews.com)
- Barry Meier – Study of Medical Device Rules Is Attacked, Unseen (earlsview.com)
- 510(k) approval process is ‘too big to fail – no matter how flawed it may be (medcitynews.com)
- FDA should invest in developing a new medical device clearance process (medicalxpress.com)
- U.S. advisers call for overhaul of FDA device approval process (msnbc.msn.com)
- FDA should invest in developing a new regulatory framework to replace flawed 510(k) medical device clearance process (eurekalert.org)