Latest Center for Devices and Radiological Health Stories

February Meeting will Complement IOM Study SILVER SPRING, Md., Jan. 22 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that it has 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 certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year. (Logo:...

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by the...

According to an independent study released on Tuesday, the U.S. Food and Drug Administration frequently gives approval to cardiovascular devices based on weak evidence from studies that are often compromised by poor methodology and bias. For the report, which was published in the prestigious Journal of the American Medical Association, researchers reviewed 123 of the FDA's summaries for some 78 applications submitted by the makers of various cardiovascular devices.  Most of the devices,...

FDA to request premarket clinical data for new versions of these devices SILVER SPRINGS, Md., Oct. 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries. (Logo:...

Awardees will work with industry and the FDA to address unmet pediatric device needs WASHINGTON, Sept. 21 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced the awarding of three grants to stimulate the development and availability of medical devices for children. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) A panel of six experts with experience in medicine, business, and device development reviewed 16 applications for the grants, which will...

Adaptive trials leader and CDRH regulators join to create Bayesian trial design and analysis software standard CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Cytel Inc., a leading provider of biostatistical software and clinical trial design services, today announced the signing of a Cooperative Research And Development Agreement (CRADA) with the Center for Devices and Radiological Health (CDRH), a division of the United States Food and Drug Administration (FDA). The agreement acknowledges...

Uniting the Venture Capital Community to Drive Innovation through Investment Opportunities in the Multi-Billion Dollar Medical Device Market MINNEAPOLIS, March 26 /PRNewswire/ -- The 510(k) program is under siege from within and outside of the FDA. Eight scientists complained in a letter to Congress that CDRH management is overruling their scientific determinations requiring more data for 510(k)s. They followed that complaint to Congress with another letter to the Obama Administration...

About Regulatory Issues in Telemedicine, Regenerative Medicine, More ROCKVILLE, Md., March 19 /PRNewswire-USNewswire/ --Six expert representatives from the US Food and Drug Administration (FDA) will be among the speakers to address several hundred healthcare product regulatory professionals who will gather in San Francisco next month. The Regulatory Affairs Professionals Society (RAPS) will convene its 2009 RAPS Horizons Conference & Exhibition, 1-3 April at The Fairmont San Francisco....

The Project on Government Oversight, an independent watchdog group, is claiming that the government has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices, the Associated Press reported.The group said that the Food and Drug Administration has dramatically reduced inspections of "good laboratory practices" at facilities that do the earliest testing of medical devices. A report the group released on Wednesday said such inspections...

An in-depth investigation into certain medical devices has uncovered that many have won government approval without a close scientific review. Congress ordered the Food and Drug Administration years ago to resolve the issue, but the Government Accountability Office said in a report that during the four years between 2003-2007, the agency approved 228 medical devices without a full-scale review. According to the consumer group Public Citizen many devices approved under the less rigorous...