TITLE

CDRH announces priorities for 2010

PUB. DATE
January 2010
SOURCE
Medical Device Daily;1/26/2010, Vol. 14 Issue 16, p9
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the priorities of the U.S. Center for Devices and Radiological Health (CDRH) for 2010. The CDRH is planning to review the 510(k) process and its document states that any planned changes to the program will be released by September 30, 2010. The CDRH also has plans to address Class III devices currently allowed to enter the market through the program.
ACCESSION #
47734492

 

Related Articles

  • Are current regulations for approval of in vitro diagnostic devices adequate? Levine, Dorothy; Grossberg, Richard; Tilton, Richard; Banks, Peter; Rosenfeld, Alvin; Levine, D; Grossberg, R; Tilton, R; Banks, P; Rosenfeld, A // JAMA: Journal of the American Medical Association;7/8/98, Vol. 280 Issue 2, p187 

    Reports on the need for updated regulations for government approval of in vitro diagnostic devices. The two ways medical devices are marketed; The role of the United States Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) in ensuring medical devices are...

  • Emergo Group analysis: 510(k) times up, but clearances down. McCARTY, MARK // Medical Device Daily;6/22/2011, Vol. 15 Issue 115, p1 

    The article reports on the release in 2011 by Amergo Group of an analysis of 510(k) clearances made by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) over the past five calendar years. Emergo found that the agency has cleared fewer 510(k) even as...

  • FDA eyes publicizing firms offering best product quality. MCCARTY, MARK // Medical Device Daily;11/2/2011, Vol. 15 Issue 210, p1 

    The article deals with the plan of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA) to boost medical-technology product quality. A document released by the agency details its justification for the initiative. Several barriers to reliable devices are...

  • Shuren; timetable for 510(k) changes en route.  // Biomedical Business & Technology;Jan2011, Vol. 34 Issue 1, p24 

    The article deals with the statement issued by Jeff Shuren of the U.S. Center for Devices and Radiological Health (CDRH) at a December 1, 2010 town hall meeting hosted by the Massachusetts Medical Device Industry Council. According to the statement, concerns were raised by the industry on the...

  • Speeding Toward a Cure: Regulation in the 21st Century. Arrowsmith, Ranica // Medical Product Outsourcing;Apr2015, Vol. 13 Issue 3, p48 

    The article reports regulatory developments in the medical device manufacturing industry in the U.S. as of April 2015. It focuses on the efforts by the Food and Drug Administration (FDA) and the House of Representatives Committee on Energy and Commerce to improve the sector. Also cited are the...

  • FDA Ponders Regulation and Innovation. Voelker, Rebecca // JAMA: Journal of the American Medical Association;4/20/2011, Vol. 305 Issue 15, p1523 

    The article discusses initiatives to be launched by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiologic Health (CDRH) to boost innovation and development of cutting-edge medical devices. Plans for an upgrade of the 510(k) clearance process, a way for low- to...

  • FDA Releases New Guidance on Patient Preference Information in Device Approvals.  // Medical Product Outsourcing;Jun2015, Vol. 13 Issue 6, p21 

    The article reports on the issuance by the U.S. Food and Drug Administration (FDA) in 2015 of a draft guidance for the collection and use of patient preference information (PPI) in device approvals. Topics covered include the patient involvement in medical device development, the launch of the...

  • Maisel to take post at CDRH as head of new science office. McCARTY, MARK // Medical Device Daily;8/4/2010, Vol. 14 Issue 150, p1 

    This article offers a look at changes at the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) and its 510(k) program. One of the changes include the appointment of Bill Maisel as inaugural deputy director for science at CDRH. According to CDRH Director Jeff...

  • FDA changes afoot? Rhea, Shawn // Modern Healthcare;8/17/2009, Vol. 39 Issue 33, p0010 

    This article reports on the looming overhaul of the U.S. Food and Drug Administration's (FDA) medical-products review programs, according to observers. FDA Commissioner Margaret Hamburg announced the resignation of Daniel Schultz, director of the agency's Center for Devices and Radiological...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics