We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Government and industry stakeholders at a public workshop on health IT found plenty of agreement, but few concrete proposals for a path forward. Read More
A chief architect of a 2007 law promoting the development of medical devices for children has asked the FDA to provide evidence it is making progress on meeting its goals. Read More
San Diego devicemaker Dr. Joel Kaplan, Inc., received an FDA warning letter for off-label claims about its penis pumps, including advertising the devices online to fix penile curvature. Read More
Devicemakers often misuse voluntary consensus standards in premarket submissions, the FDA says, by using versions of standards that the agency doesn’t recognize or using consensus standards that don’t apply to their specific device or testing methods. Read More
CDRH brought in nearly 50 percent more device user fees in fiscal year 2013 than in 2012, according to the FDA’s quarterly report on MDUFA performance. Read More
The National Institute for health and Care Excellence has issued final draft guidance updating advice on the most clinically and cost-effective choices for devices to treat irregular heartbeats or heart failure. Read More
Manufacturers of surveying, leveling or alignment laser products cannot avoid the SLA designation simply by promoting their lasers for scientific, general purpose or other uses, the FDA says. Read More