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Latest Center for Devices and Radiological Health Stories

2011-07-29 08:56:00

CDRH, IOM Committee Members, Industry and Stakeholders to Discuss WASHINGTON, July 29, 2011 /PRNewswire-USNewswire/ --On the heels of the release of the highly anticipated Institute of Medicine (IOM) report, Public Health Effectiveness of the FDA 510(k) Clearance Process, The Food and Drug Law Institute (FDLI) is holding a "Dialogue" on the report August 4 in Washington, D.C. The half-day meeting, called "An FDLI Dialogue: A First Look at the IOM Study of the 510(k) Clearance Process,"...

2011-07-29 08:10:00

Agency continues to improve device review process SILVER SPRING, Md., July 29, 2011 /PRNewswire-USNewswire/ -- The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The FDA commissioned the report in September 2009. While none of the IOM's recommendations are...

2011-07-26 13:07:00

SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- Do you have questions about medical devices you use at home? There are many such devices, from ventilators to blood pressure monitors. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Learn more during a 30-minute webinar hosted by the Food and Drug Administration's Center for Devices and Radiological Health. An FDA expert will discuss how FDA plans to address the increased use of medical devices in the home and will...

2011-07-26 08:54:00

SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k)...

2011-07-25 14:17:00

SILVER SPRING, Md., July 25, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of July 25, 2011. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Events and Speeches for the...

2011-07-19 08:00:00

Agency seeking public input on its proposed approach SILVER SPRING, Md., July 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select...

2011-07-12 10:00:00

Part of agency's efforts to promote development of personalized medicines and diagnostics SILVER SPRING, Md., July 12, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics - tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft...

2011-07-07 10:44:00

SILVER SPRING, Md., July 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The draft guidance lists 30 different device types, including common urine and...

2011-06-20 11:51:00

Guidance outlines recommendations for clinical trials and pathway to market approval SILVER SPRING, Md., June 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Type 1 diabetes is a chronic condition in which the pancreas produces little or no...

2011-05-31 11:23:00

SILVER SPRING, Md., May 31, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights for this week from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of May 31, 2011. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Meetings, Workshops, and...


Word of the Day
endocarp
  • The hard inner (usually woody) layer of the pericarp of some fruits (as peaches or plums or cherries or olives) that contains the seed.
This word comes from the Greek 'endon,' in, within, plus the Greek 'karpos', fruit.
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