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The FDA issued a final rule Aug. 23 amending the classification of noble and base metal alloys used in dental work to exempt them from premarket notification requirements.
The Global Harmonization Task Force (GHTF) has revamped its guidance document on medical device labeling to add requirements for in vitro diagnostic products.
In a major enforcement action last week, the FDA filed a complaint seeking civil penalties of more than $4.3 million against the owners and employees of a Florida health center that performed mammograms without agency certification.
Tyco Healthcare subsidiary Nellcor has initiated a nationwide recall of its CapnoProbe product following reports that the device might have caused life-threatening infections in 11 patients, including two who later died.
Cyberonics executives confirmed Aug. 25 that the company intends to appeal the FDA’s recent decision to reject its implantable vagus nerve stimulation (VNS) therapy for patients with treatment-resistant depression.
Small manufacturers that submit premarket approval (PMA) applications to the FDA before formally qualifying as a small business under the Medical Device User Fee and Modernization Act (MDUFMA) will have to pay the full user fee for that application, according to a revamped guidance document issued by the agency Aug. 20.
The Centers for Medicare & Medicaid Services’ (CMS’) highly anticipated coverage decision on carotid stents — once expected in December — may not come until the first quarter of 2005, according to industry observers.
The final version of the National Institutes of Health’s (NIH’s) plan to fight the obesity epidemic calls for a $400 million commitment this year and a $440 million commitment in 2005 to fund a multipronged approach that combines pharmacologic, surgical, behavioral and other medical antiobesity strategies.