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Latest Radiological Health Stories

2011-10-17 11:54:00

Classification of "preamendment" device clarifies FDA review process SILVER SPRING, Md., Oct. 17, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) External pacemaker pulse generators are used temporarily to regulate a...

2011-10-04 11:07:00

Network will help quickly address regulatory concerns, broaden staff knowledge of new and emerging technologies SILVER SPRING, Md., Oct. 4, 2011 /PRNewswire-USNewswire/ -- FDA's Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also...

2011-10-03 10:41:00

SILVER SPRING, Md., Oct. 3, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The report, "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital...

2011-09-06 12:29:00

Training a key step to improving device review program, strategic priorities SILVER SPRING, Md., Sept. 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The Reviewer Certification...

2011-02-08 09:00:00

DARPA-funded prosthetic is first test case SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ --Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly. (Logo:...

2011-01-19 12:00:00

Goals are to foster device innovation, protect patient safety SILVER SPRING, Md., Jan. 19, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Key actions include: Streamlining the "de novo" review process for certain innovative, lower-risk medical devices, Clarifying...

2010-10-18 12:47:00

HACKENSACK, N.J., Oct. 18 /PRNewswire/ -- ReGen Biologics Inc. is taking exception to the FDA's Center for Devices and Radiological Health's (CDRH) Thursday announcement of a plan to rescind the 510(k) clearance of the company's Menaflex knee implant. "For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510 (k) program is totally unbelievable," said Gerald E....

2010-04-26 14:28:00

Goal is improved discussion and flow of information SILVER SPRING, Md., April 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) The changes were prompted by an increasing number of medical device advisory...