The Food & Drug Administration released the pre-market approvals it granted during August:
FDA releases August 510(k) clearances
Food & Drug Administration (FDA)
FDA raises user fees
The Food & Drug Administration boosted the user fees medical device makers pay for applications for clearance or approval from the federal watchdogs.
The new fee schedule for fiscal year 2011, which goes into effect Oct. 1, institutes across-the-board hikes of 8.5 percent. Companies must pay an initial fee of $2,179 to register with the FDA.
FDA requires warning label update for gadolinium drugs
The Food & Drug Administration ordered gadolinium-based drug makers to update the warning labels on their products.
The contrast agent, which is used to improve image quality in magnetic resonance imaging and magnetic resonance angiography, has been associated with an increased risk for nephrogenic systemic fibrosis in individuals with kidney problems.
FDA’s Office of Device Evaluation releases 2009 review
The Food & Drug Administration department charged with evaluating medical devices issued its annual performance review for 2009, showing a slight uptick in overall submissions.
The Office of Device Evaluation’s report reveals that total submissions increased 0.6 percent from 2008 to 2009.
FDA releases July 510(k) clearances
The Food & Drug Administration released the pre-market approvals it granted during July:
FDA begins measuring its own performance, transparency
The Food & Drug Administration today launched a rating system for its organizational performance.
The federal watchdog agency’s new system, “FDA-TRACK,” is designed to meet President Barack Obama’s attempts to make the U.S. government more transparent and collaborative, with more public participation. The acronym stands for transparency, results, accountability, credibility and knowledge-sharing.
SonoSite wins FDA nod for catheter guidance system
SonoSite Inc. (NSDQ:SONO) won 510(k) clearance from the Food & Drug Administration for its LumenVu catheter guidance system.
The Bothell, Wash.-based portable ultrasound maker said it designed the system to increase the accuracy of peripherally inserted central catheter placement. Physicians incorrectly place 30 percent of peripherally inserted central catheters, according to the company.
FDA releases July PMA approvals
The Food & Drug Administration released the pre-market approvals it granted during July:
FDA to examine user fees
Medical device companies, whose user fees have funded an increasing share of Food & Drug Administration’s device review budget, will have a chance to weigh in on how well the program is working at a Sept. 14 public workshop.
The federal watchdog agency will offer its own views and solicit input from consumers, patients, healthcare professionals, scientific and academic experts at the meeting, which is scheduled a full two years ahead of the September 2012 expiration date for the current medical device user fee program.
FDA to hold nanotech workshop
The Food & Drug Administration wants to talk about nanotechnology.
The watchdog agency’s Center for Devices and Radiological Health is planning a public workshop on medical devices that employ the molecular-level technology.
FDA warns Biomet on knee replacement planning system
The Food & Drug Administration warned Biomet Inc. that its personalized knee implant planning offering, the Signature Personalized Patient Care system, lacks approval or clearance to be on the market in the U.S.
In a July 27 warning letter, the FDA warns the Warsaw, Ind.-based firm that the system, which uses MRI and CT scans to develop a pre-operative plan for implanting Biomet’s Vanguard knee replacement, does not have pre-market approval, an investigational device exemption or 510(k) clearance from the watchdog agency.
