The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The Food & Drug Administration’s Center for Devices and Radiological Health will release its proposed changes for the 510(k) regulatory pathway for medical devices, President Barack Obama revealed today.
In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.
The Food & Drug Administration’s Center for Devices and Radiological Health saw 29 percent increase in complaints last year, logging a record high of 171 in 2010.
The surge in complaints is less dramatic than the 45 percent increase the agency saw from 2009 to 2010, but the number of contacts, comprised of complaints, disputes and inquiries the agency fielded rose from 250 to 414, up 66 percent.
U.S. marshals seized all the dental devices from a Fla.-based company after a Food & Drug Administration inspection turned up violations in the company’s manufacturing processes.
Acting under court order from the FDA, the marshals on Jan. 5 and 6 removed the products from Hialeah, Fla.-based Rite-Dent Manufacturing Corp., according to the watchdog agency. The seized property is valued at valued at $208,910, the agency said.
Spire Corp.’s (NSDQ:SPIR) medical device unit sued Creganna-Tactx Medical subsidiary Catheter and Disposable Technology Inc. over an alleged breach of contract related to the manufacture of hemodialysis catheters.
The unit, Spire Biomedical Inc., yesterday filed a suit in U.S. District Court in Massachusetts alleging that CDT failed to assemble the catheters in accordance with its designs.
AngioScore Inc. recalled its 0.018″ OTW-design AngioSculpt PTA scoring balloon catheter.
"A small number" of the devices fragmented while in use, and though no injuries have been reported, the Food & Drug Administration branded the recall as Class I.
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD December 2010
DEVICE: V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
VALERITAS, LLC 510(k) NO: K100504(TRADITIONAL)
ATTN: SCOTT HUIE PHONE NO : 508 845 8744
800 BOSTON TURNPIKE SE DECISION MADE: 01-DEC-10
SHREWSBURY MA 01545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CCPOINT
EURO-DIAGNOSTICA AB 510(k) NO: K093908(TRADITIONAL)
The Food & Drug Administration announced on Jan. 5 that its deputy commissioner, Joshua Sharfstein, would be leaving to take over Maryland’s health department.
The next day, MedCity News floated the idea of Cleveland Clinic cardiologist Dr. Steven Nissen replacing him.
He’s a long shot. But Cleveland Clinic cardiologist Dr. Steven Nissen may be exactly what the troubled Food & Drug Administration needs.
Conventional wisdom is that the departure of FDA deputy commissioner Joshua Sharfstein represents an olive branch to newly empowered Congressional Republicans, who viewed Sharfstein as hostile to the industry. Sharfstein sought to crack down on drug and device companies and was once a staffer with a Democratic Congressman. So it could be that Sharfstein’s replacement will be someone who’s viewed as more industry friendly and therefore more palatable to Republicans.
Food & Drug commissioner Dr. Margaret Hamburg named her office’s top lawyer, John Taylor III, to be the temporary replacement for outgoing deputy commish Dr. Joshua Sharfstein.
Taylor, counselor to the commissioner will take on the new role Jan. 10, an FDA spokeswoman told MassDevice. Sharfstein’s last day on the job is Jan. 7.
Sharfstein, formerly Baltimore’s top public health official, is slated to be named secretary of health and mental hygiene for Maryland by Gov. Martin O’Malley.
Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, is stepping down for the top job in Maryland’s public health department, according, un-named officials told the Wall Street Journal.
Ev3 Inc. initiated a recall for certain lots of its NanoCross .014″ OTW PTA dilatation catheter.
The Plymouth, Minn.-based Covidien plc (NYSE:COV) subsidiary is taking the peripheral artery surgical instruments off the shelves because of a potential for the catheter’s shaft to crack or break during procedures using balloons to dilate blood vessels.
