FDA

Tougher Medical Device Rules On The Way

SAN FRANCISCO — Regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety, according to information posted yesterday on the Food and Drug Administration’s website. Discuss COMMENTS (0) Coming are guidelines for manufacturers, training programs for patients and family members, and labeling and testing standards for [...]

FDA streamlines medical device voting process

FDA expert panels plan to change the way they review and discuss data during public hearings regarding medical devices being considered for premarket approval. Effective May 1, 2010, medical device advisory committees will vote on the safety, effectiveness and risks vs. benefits of devices for which premarket approval applications have been submitted. In the past, [...]

GE’s misleading drug claims

The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has reviewed GE Healthcare’s Web site for its contrast agent, Visipaque (iodixanol) Injection, and deemed the promotional material “misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with Visipaque.” Therefore, the agency sent a letter to GE, stating that it [...]

FDA Posts New Draft Guidance on Computer-Assisted Detection Devices Applied to Radiological Images and Radiological Data (CADe) :: Medical Connectivity

This is an interesting summary of an extremely complex document describing what appears to be a modification to the FDA’s classification of devices which might have a substantial impact on our prediction technologies. All of the detail relates to radiology technologies, in which case it doesn’t relate to what we’re doing (as yet any way). [...]

FDA Device-Process Review Adds To Pressure On Device Makers

By Jon Kamp Of DOW JONES NEWSWIRES The Food and Drug Administration‘s review of a fast-track approval pathway for medical devices opens the door for changes to a process manufacturers commonly use to get products to market cheaply and quickly. Among devices companies, more stringent “510(k)” rules would likely affect replacement joint makers such as [...]

Fetal Monitors Produce Inaccurate Results

September 12, 2009 by enjoybirth Well, this is disconcerting.  I wonder how many unneccessary cesareans these machines caused.  How many more will they cause if hospitals don’t get these models replaced or fixed?

Clicky Web Analytics