By: Alberto Gutierrez, Ph.D.
510(k) reforms
Mass. Sen. hopeful Elizabeth Warren on the device tax, the FDA and a climate for innovation
A climate for innovation
by Elizabeth Warren
When it comes to turning good ideas into innovative businesses, Massachusetts has always set the standard. From Alexander Graham Bell’s telephone in 1876 to the microwave in 1945 to iWalk’s bionic ankle just last year, we’ve proven that we’re the most innovative place in the world.
MassDevice.com +7 | The top 7 med-tech stories for the week of March 26, 2012.
Happy 3rd birthday, MassDevice!
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
U.S. poll shows “overwhelming” support for more oversight of medical devices
A new survey of U.S. consumers pits safety concerns against the need for product innovation, finding that the vast majority of respondents were more concerned about patient safety than about speeding devices to market.
Of 1,000 people polled, 82% responded that "preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation."
CDRH head: End substantial equivalence for some 510(k) applications
By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls.
MassDevice.com +7 | The top 7 med-tech stories for the week of February 13, 2012.
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
A Von Eschenbach sighting
Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning’s Wall Street Journal:
(Reform) means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.
Focus on safety, not efficacy, says former FDA chief | MassDevice.com On Call
MASSDEVICE ON CALL — Former FDA commissioner Andrew von Eschenbach turned heads yesterday by calling on the federal watchdog agency to abandon efficacy testing when considering new drug and device applications.
Eschenbach, who led the agency from 2006 to 2009, called for an overhaul of the FDA’s mission statement and urged Congress to leverage user fee negotiations to reassess the agency’s performance.
Consumer group demands more med-tech oversight from MDUFMA III | Regulatory Roundup
Consumer Union demanded that a new user fee deal the medical device industry brokered with the FDA include more stringent oversight of med-tech makers.
"We shouldn’t be used as guinea pigs when it comes to something as serious as a medical implant," according to the organization’s website. "Medical devices should not be ticking time bombs!"
Democrats set sights on medical device safety regulation
By Frank Fazio
"Forewarned, forearmed; to be prepared is half the victory." – Miguel de Cervantes
Ink-like clouds suffused over our nation’s capitol as a murder of crows converges upon fresh carrion. As the atramentous nebulae congealed over the Hill, the icy, soul-sucking breath of regulators chilled the device industry like Harry Potter’s tormenting dementors. Yes, my friends, Congress is coming and it has medical devices locked in the cross-hairs.
MassDevice.com +3 | The top 3 med-tech stories for February 2, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.