By Stewart Eisenhart, Emergo Group
The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.
CDRH: 577 warning letter citations issued in 2010
Food & Drug Administration (FDA)
Shuren: Northwestern survey “validates actions we are already taking”
Dr. Jeffrey Shuren, head of the FDA’s medical device arm, said a Northwestern University survey on the 510(k) clearance program “validates actions we are already taking” to improve the regulatory path for almost all medical devices.
“These efforts may not grab headlines, but they represent true actions we’re taking to promote innovation and protect the public health,” Shuren told an audience in Washington, D.C. this morning following a presentation of the survey results. “The 510(k) program has to adjust, but it has to adjust properly.”
510(k) reform: More clarity needed in FDA review of medical devices
Increasing numbers of medical device makers will look offshore to introduce new medical technologies unless the FDA can make its 510(k) review process more predictable, according to researchers from Northwestern University.
House proposes 12 percent cut to FDA’s budget
Republicans in the U.S. House of Representatives unveiled a 2012 appropriations bill that would cut 11.5 percent from the FDA’s budget.
The proposal comes after several GOP attacks on the FDA, including a February inquiry by Rep. Joe Pitts (R.-Pa.) into why the FDA’s medical device approval process takes longer than the European regulatory process.
Last week medical device advocate Rep. Erik Paulsen (R-Minn.) announced intentions to revamp FDA policies that he says reduce medical technology jobs across the country.
Risky regulations: Is the FDA’s clunky process impeding progress?
U.S. Rep. Erik Paulsen (R-Minn.) announced plans to push legislation to modernize and streamline FDA processes at the MedTech Investing Conference in Minneapolis last week.
High on Paulsen’s priorities are the development of an "Innovation Pathway" for pioneering medical devices and blocking a proposed $20 billion tax on the medical device industry.
[sead]Paulsen said he expects to meet with Dr. Jeffrey Shuren, head of the federal watchdog agency’s medical devices arm, to discuss his proposals.
Cellulite: Cynosure touts regulatory wins for laser fat-removal products | Regulatory roundup
Cynosure Inc. (NSDQ:CYNO) officials said the company has won international regulatory approval for two of its cellulite reduction systems, including the SmoothShapes laser liposuction device that sucked $40 million out of now-defunct Elemé Medical Inc.
FDA warns home genetic test makers on medical claims
The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn’t approved.
The FDA wants the companies; American International Biotechnology Services, Lumigenix Inc and Precision Quality DNA — to either furnish evidence of device approval or make a case that their products don’t fall under the FDA’s purview.
pSivida, Alimera want FDA to give eye treatment another look | Regulatory roundup
BioMimetic Therapeutics claws back a chunk on FDA panel nod
BioMimetic Therapeutics (NSDQ:BMTI) clawed back a chunk of the share value it lost earlier this week after the FDA released a dim review of BMTI’s Augment bone graft product, as an advisory panel for the federal watchdog agency recommended approving the treatment.
BMTI shares were up about 8 percent in pre-market trading today, to $9.91, after plunging more than 35 percent from a May 9 close of $13.39.
BioMimetic Therapeutics plunges on dim FDA view of Augment bone graft
Shares of BioMimetic Therapeutics (NSDQ:BMTI) continued their slide today after plunging 35.3 percent yesterday on news of the FDA’s dim view of its Augment bone graft product.
FDA probes for data on metal-on-metal hip implants
The FDA asked Johnson & Johnson (NYSE:JNJ) and a score of other medical device makers for data on metal levels in the blood of patients implanted with metal-on-metal hip implants.
