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A study of Boston Scientific’s Express SD Renal stent shows that the device reduces the rate of restenosis, or narrowing of an artery from benchmark levels, the company reported.
An FDA advisory panel recommended that nonprescription asthma inhalers should be removed from the market because they contain chlorofluorocarbons (CFCs) that harm the ozone layer.
The FDA has approved a revised label for the Cypher drug-eluting stent, stating that simultaneous use of several of these devices presents no increased risk of heart attack as compared to use of multiple bare metal stents.
The FDA announced late last week an initiative to improve its postmarket monitoring of devices, a move that comes in the aftermath of high-profile device-related scandals over the past year.
The FDA’s premarket device reviews are too long and unpredictable to bring products to market efficiently, according to medical device industry leaders who also argue the agency has failed
to explain exactly what it expects manufacturers to provide in the
reviews.
A top FDA official has raised concerns about device manufacturers using advertisements to make comparative claims about products — a challenge that comes as the agency considers reforming direct-to-consumer (DTC) advertising.
The FDA has scheduled two public events to discuss current medical device regulations and future legislation to update the 2002 Medical Device User Fee and Modernization Act.
The FDA has been meeting some fiscal 2005 performance goals established under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), but it is unclear whether the agency will reach all of those targets because only limited measurable data is available, according to a new report from the Government Accountability Office (GAO).
The FDA recently released an updated guidance concerning industry documentation in support of software submissions as part of the agency's ongoing efforts to revise its guidelines to enhance their clarity and timeliness regarding emerging technologies.
The FDA issued a final rule late last month to address the reclassification of a dental bone grafting product from Class III to Class II with special controls — a decision that paved the way for the reclassification of other dental bone grafting materials.