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

Recommendations address when and how radiation therapy should be used and outline best practices for patient-centered care

Figure 1. The guideline also includes treatment algorithms for initial local management (Figure 1) and local management following an unplanned excision (Figure 2).

News | Radiation Therapy | July 27, 2021
July 27, 2021 — A ...
The global medical imaging and informatics market is experiencing dynamic changes with the emergence of advanced technologies, evolving clinical and administrative needs, and the introduction of new policies and regulations, which is forcing industry participants to innovate to maintain their competitive edge

Getty Images

News | Coronavirus (COVID-19) | July 26, 2021
July 26, 2021 — The global medical imaging and informatics market is experiencing dynamic changes with the emergence
Radiation oncologists urged Congress to reverse proposed CMS cuts and create more equity in access to cancer treatments

Getty Images

News | Radiation Oncology | July 26, 2021
July 26, 2021 — A record number of radiation oncologists met with Congressional leaders and staff last week as part o
Videos | Artificial Intelligence | July 22, 2021
This is an overview of trends and technologies in radiology...
64-Year-Old Man With Clear Cell Likelihood Score (ccLS) 5 Renal Masses

64-Year-Old Man With Clear Cell Likelihood Score (ccLS) 5 Renal Masses. Coronal T2-weighted single shot fast spin echo and coronal T1-weighted fat-saturated spoiled gradient echo acquired during corticomedullary phase—ccLS5 lesion outlined red for clarity.

News | Magnetic Resonance Imaging (MRI) | July 22, 2021