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Makers of implantable radio-frequency transponder systems can soon begin marketing their devices without being subject to 510(k) premarket notification requirements, according to an FDA guidance document.
The FDA published a final guidance Nov. 29 outlining recommendations on the use of symbols on labeling for in vitro diagnostic devices (IVDs) to harmonize standards of conveying pertinent and required information about the devices.
In light of concerns that its device user fee program will die without additional congressional funding, the FDA is urging the device industry to throw its weight behind the Office of Management & Budget’s (OMB’s) “trigger fix” proposal, which would allow the program to continue through at least fiscal 2006.
The FDA published a detailed agenda last week for its Nov. 18 meeting to discuss its progress in implementing the various provisions of the Medical Device User Fee and Modernization Act (MDUFMA).
Aortic connector device failures and thrombus linked to coronary stents were among the leading adverse events reported to the Center for Devices & Radiological Health (CDRH) in fiscal 2003, according to the agency’s recently released annual report.
Acting FDA Commissioner Lester Crawford made his first major appointment last week, naming Daniel Schultz director of the Center for Devices and Radiological Health (CDRH).
The FDA’s Dispute Resolution Panel is an effective tool for firms that disagree with decisions made by the Center for Devices and Radiological Health (CDRH), but it should be considered a last resort due to the time and financial resources it takes to see an appeal come to fruition, according to CDRH Ombudsman Les Weinstein, who spoke June 14 at the Medical Device & Manufacturing meeting in New York City.
Despite objections from some panel members, an FDA advisory panel voted last week to recommend approval for Cyberonics’ nerve stimulation implant as a treatment for chronic depression.
The FDA has rejected Cardima’s premarket approval (PMA) application for its Revelation Tx microcatheter, marking the second time in a year that the agency has derailed the device.
The healthcare industry is in dire need of a national, centralized repository of recalls to ensure hospitals can respond to device alerts quickly, but it isn’t likely to get one anytime soon, according to industry experts and regulatory officials.