Category: Capitol Hill
FDA medical device chief Jeffrey Shuren spars with the House Energy & Commerce Committee's subcommittee on Health over the FDA's proper role in regulating mobile health and medical applications.
The conversation got a bit heated this week as the House Energy & Commerce Committee's subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications.
The White House's Office of Management & Budget confirms that the federal sequester has drained about $85 million in user fees from the FDA, and more cuts may be on the way.
Federal officials confirmed this week that the government shutdown and budget sequester had drained some $85 million from the FDA's coffers, all from the fees that medical device and pharmaceutical companies pay directly to the agency.
Physician-owned distributors increase the cost of spinal surgeries and create the potential for conflicts of interest, according to a report from the U.S. Health & Human Services Dept.'s inspector general.
The cost of spinal fusion surgeries is boosted when hospitals purchase medical devices from physician-owned distributors, according to Daniel Levinson, the inspector general of the U.S Health & Human Services Dept.
The POD businesses also create the potential for conflicts of interest, according to the report, which prompted a call for increased scrutiny of PODs from 3 senators last week.
A bipartisan group of House Reps introduces a new bill that would limit keep the FDA's mHealth oversight of out of software that is a component of a regulated medical device.
A new House bill co-sponsored by a bipartisan group of lawmakers aims to cut deep into the FDA's newly finalized oversight of mobile medical apps, keeping regulation only to programs that complement medical technologies or those that turn a mobile device into a medical one.
Senate Health Committee chairman Tom Harkin (D-Iowa) lambastes the medical device industry's efforts to repeal the 2.3% sales tax created by the Affordable Care Act, saying that the levy "won't hurt them one bit."
MASSDEVICE ON CALL — Medical device tax repeal efforts have made friends across party lines and in both houses of Congress, but Senate Health Committee chairman Tom Harkin isn't one of them.
In harsh comments made yesterday Harkin characterized the debate over the medical device tax as a fabricated controversy, saying that the industry can afford to pay its share to help fund healthcare reform, Minnesota Public Radio reported.
Security concerns led doctors to shut off the wireless communication capacities of former U.S. Vice President Dick Cheney's implanted defibrillator.
MASSDEVICE ON CALL — When former U.S. Vice President Dick Cheney was fitted in 2007 with an implanted defibrillator, doctors ordered the manufacturer to shut off the device's wireless communication capacities, out of fear that the device may be vulnerable to cyber-attack.
In a 60 Minutes interview published over the weekend, Cheney's cardiologist Dr. Jonathan Reiner said that the was aware of cybersecurity concerns with medical devices and that he felt it was necessary to protect the prominent public figure from malicious hackers.
The user fees medical device companies pay to have their products reviewed by the federal watchdog agency can begin to be collected for fiscal 2014 now that the federal shutdown is over.
The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over.
The watchdog agency announced new rates for the fees in August, but couldn't begin collecting them when the fiscal year began Oct. 1 because of the shutdown that began that day.