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Medical Devices

November 27, 2012 | Daily News

FDA's device center plans to draft guidance this fiscal year on distinguishing and reporting recalls from product enhancements, the types of communication used during submission reviews, agency decisions for Investigational Device Exemption clinical investigations, the eCopy program and the appropriate use of voluntary consensus standards for premarket submissions, according to a list released by the agency.

November 26, 2012 | Daily News

While still optimistic that Congress will repeal the ACA's device tax, key industry officials say that device companies still need to “budget” for the device tax's possible Jan. 1 implementation and the economic effects of the tax are already being felt across the industry, even though the IRS has yet to issue a final rule on the ACA provision.

November 21, 2012 | Daily News

FDA is examining ways it could allow companies to pre-sell and pre-position companion diagnostics approved through the pre-market approval process, an agency official told FDA Week following comments from one industry stakeholder that rules barring pre-placement of these devices are hindering initial widespread use of these products.

November 21, 2012 | Daily News

Final guidance outlining FDA's policy on companion diagnostics will closely mimic draft guidance released last year, outlining the agency's preference for co-approval of drugs and devices intended to be used together, its definition of a companion diagnostic and for drug labels to refer to use of an agency approved or cleared device, an FDA official said.

November 16, 2012 | Daily News

On the eve of Friday's White House meeting with congressional leaders, Rep. Phil Gingrey (R-GA), a key member of the GOP Doctors Caucus, listed several areas where he believed his party and Democrats could find common ground as they address the impending fiscal cliff -- notably holding Medicare beneficiaries harmless in the process, repealing the reform law's highly controversial IPAB, lowering the reform law's exchange subsidies, repealing the law's medical device tax and phasing in an increase to the Medicare eligibility age.

November 08, 2012 | Daily News

Health care lobbyists expect that proposals to structurally transform Medicare into a premium support model will take a back seat in upcoming fiscal talks given President Obama's reelection win and Democrats' stronger hand in the Senate, and providers are bracing for Congress to pursue traditional cuts outlined in Simpson-Bowles and other recent deficit-cutting plans, a message that the American Hospital Association on Wednesday communicated to its members as it gears up to beat back those efforts.

November 08, 2012 | Daily News

Union representatives and progressives whose ground game helped propel President Obama into a second term are sending a clear message to the White House that any budget agreement must support policies that do not impact Medicare or Medicaid benefits and do not shift costs to beneficiaries or the states.

November 07, 2012 | Daily News

House Energy and Commerce Committee top Democrat Henry Waxman narrowly edged out his opponent in an election that will see big changeovers for the committee, especially with the potential for the departure of 10 members on both sides of the aisle.

November 06, 2012 | Daily News

FDA's Office of Device Evaluation has set up additional review divisions and branches to increase management oversight, better align product areas and accommodate new staff hired as part of the Medical Device User Fee Act, the agency confirmed to FDA Week.

October 25, 2012 | Daily News

A Senate Finance Committee investigation alleging there were “questionable” ties between medical device manufacturer Medtronic and physician consultants, including collaboration on studies that may have inaccurately represented a bone-growth product's risks, shows the importance of the Physician Payments Sunshine Act, the author of the law said following release of the investigation's findings Thursday (Oct. 25).

October 25, 2012 | Daily News

The administration is facing pressure from lawmakers and radiation oncologists to back off a proposed $300 million Medicare payment cut for certain radiation treatments, with the American Society for Radiation Oncology (ASTRO) telling White House Office of Management and Budget officials Monday (Oct. 22), after having relayed the same message to CMS staff in previous meetings, that the cuts could lead to clinic closures and consolidations which would decrease patients' access to facilities.

October 15, 2012 | Daily News

Some items FDA plans to review in determining if a 510(k) medical device submission is complete can only be evaluated if a substantive review has been conducted, a departure from the intent of the “refuse to accept” checklist agreed to during user fee negotiations, the medical device industry tells FDA in comments on draft guidance outlining the agency's policy in this area.

October 02, 2012 | Daily News

Plans by the Federal Communications Commission to hire a health care director, push to make mobile health technology a routine medical practice within five years, and collect richer data on broadband and telehealth applications could create more opportunities for the agency to collaborate with FDA on policies that will promote new mobile health technologies, an industry attorney said.

September 28, 2012 | Daily News

A new postmarket surveillance plan and expansion of the Sentinel Initiative called for by the new FDA law will help the agency improve oversight of possible information security risks associated with implantable wireless medical devices, FDA said in response to findings by Congress' investigative arm that the agency and medical device manufacturers have been slow to respond to information security risks resulting from intentional threats to these products.

September 25, 2012 | Daily News

The American Civil Liberties Union has for a second time asked the high court to reverse a lower court's ruling that upheld isolated gene patents, citing varying viewpoints within the administration and the courts about the patentability of genes.

September 20, 2012 | Daily News

The Senate aging committee's top Republican, Sen. Bob Corker (TN), said he remains skeptical that CMS' prior authorization demonstration that went into effect on Sept. 1 will effectively solve the waste, fraud and abuse problems plaguing the power mobility device industry, and warned that if CMS does not lower the error rate on the program into the single digits, Congress may step in.

September 20, 2012 | Daily News

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars.

September 19, 2012 | Daily News

The medical device industry may look to the lame duck session to pursue a fix allowing FDA to collect a higher level of user fees than allowed under a continuing resolution likely to be passed by the Senate this week, with possible legislative vehicles being the farm bill or legislation to avert a Medicare physician payment cut, sources said.

September 19, 2012 | Daily News

Public Citizen has petitioned FDA to stop its longstanding practice of redacting portions of documents released to Freedom of Information Act requesters without giving requesters an immediate right to appeal within the agency.

September 14, 2012 | Daily News

FDA will take a $319 million hit if mandatory across-the-board cuts take effect in January, according to an administration report released Friday (Sept. 14) outlining the impact of sequestration, which includes user fees. FDA funding advocates recently said sequestration would likely affect the fees, contrary to what was previously thought, leading to a bigger agency impact. The report also confirmed a bigger-than-expected hit to NIH, research advocates said.