News | January 25, 2010

FDA to Re-Assess Premarket Clearance for Medical Devices

The Wiimote may find some uses in the medical field.

January 25, 2010 - With more than 3,000 requests for medical devices to get 510(k) clearance each year, the U.S. Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process, which is not scheduled to be concluded for another year.

In the meantime, the FDA is internally evaluating the quality and consistency in the 510(k) process. To garner public feedback on the matter, the FDA scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear medical devices marketed in the United States.

The agency established the premarket notification process for medical devices 30 years ago, and now is holding a hearing on the process of approving medical devices, noted Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

The FDA staff will highlight issues with previously cleared devices that may support a manufacturer’s claim of substantial equivalence; challenges with assessing new technologies and scientific evidence; managing the high volume of submissions; and postmarket surveillance and new information about marketed devices.

Each of the four overview presentations will be followed by an open comment session. The meeting will be held on February 18,. 2010, meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. To attend or participate in the meeting you must register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

For more information: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497...

Related Content

Videos | Enterprise Imaging | December 14, 2018
ITN Editor Dave Fornell and ITN Contributing Editor Greg Freiherr share their insights on the vendors highlighting EI
RADxx Announces 2nd Annual Award Winners for Outstanding Leadership in Medical Imaging Informatics
News | Radiology Business | December 14, 2018
RAD Women (#RADxx), a networking group for the advancement of women in imaging informatics, recently announced the...
Videos | Artificial Intelligence | December 13, 2018
ITN Editor Dave Fornell and ITN Contributing Editor Greg Freiherr share their insights on the vendors showing AI prod
RSNA Study Shows Real-Time Indicator Improves Mammographic Compression
News | Mammography | December 12, 2018
Sigmascreening recently announced that more than 100,000 women have had mammography exams with the Sensitive Sigma...
Massachusetts Superior Court Grants Hologic Preliminary Injunction in Trade Secrets Lawsuits
News | Mammography | December 12, 2018
December 12, 2018 — A Massachusetts Superior Court granted a preliminary injunction in lawsuits by Hologic against Ch
Videos | SPECT-CT | December 12, 2018
This is a walk around of the new Spectrum Dynamics Veriton SPECT-CT nuclear imaging system introduced at the 2018 ...
Siemens Healthineers Unveils Multix Impact Digital Radiography System at RSNA 2018
News | Digital Radiography (DR) | December 11, 2018
At the 104th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 25-30 in...
Videos | Mammography | December 10, 2018
Stamatia Destounis, M.D., FACR, associate professor, University of Rochester School of Medicine, and attending radiol
FDA Clears iCAD's ProFound AI for Digital Breast Tomosynthesis
Technology | Mammography | December 07, 2018
iCAD Inc. announced clearance by the U.S. Food and Drug Administration (FDA) for their latest, deep-learning, cancer...