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Medical Devices

July 20, 2012 | Daily News

Stakeholders said proposed FDA x-ray labeling, which cautions against the device's use in children if there is not data to back up the pediatric use, could force hospitals to use the devices off-label and proposed alternatives, including labeling with the intended use of the device.

July 19, 2012 | Daily News

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.

July 17, 2012 | Daily News

HHS last month asked its Office of Inspector General to investigate the premarket review process for some medical device applications that have been caught up in FDA's controverisal employee monitoring activities, FDA said in a recent letter to Sen. Chuck Grassley (R-IA), responding to the senator's months-long probe into the employee surveillance policies.

July 13, 2012 | Daily News

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.

July 05, 2012 | Daily News

Once pending user fee legislation is signed into law FDA will need to speed up by one year its proposed timeline for applying the Unique Device Identifier system to some implantable devices to follow the new law's requirements, agency device center officials said Tuesday (July 3) as they rolled out a long-awaited UDI proposed rule.

June 27, 2012 | Daily News

BOSTON -- FDA and drug company officials said they are optimistic the agency will meet drug performance goals this time around despite the user fee bill's significant changes to the review process and the slew of reforms attached.

June 27, 2012 | Daily News

The FDA Safety and Innovation Act cleared Congress with a 92 to 4 Senate vote Tuesday (June 26) after Sen. Richard Burr (R-NC) spoke for hours on the Senate floor pointing out shortfalls of the bill, which he said was unnecessarily rushed through Congress ahead of the Supreme Court ruling on health reform and, given extra time, could have resolved several issues, including the creation of a federal track and trace system.

June 26, 2012 | Daily News

The authors of a new study that reveals metal-on-metal hip implant manufacturers initiated FDA-mandated post-market studies for only 24 of 104 products last year are hopeful that device reforms moving through Congress will avert such lags in the future, but also urge FDA to go a step further and pursue a comprehensive national device postmarket safety registry.

June 22, 2012 | Daily News

Companies developing mobile medical applications are pleased lawmakers left out of the final FDA user fee legislation a contentious Senate provision that would have slowed up FDA's issuance of a final mobile app guidance by requiring an outside working group first report to Congress on a proposed regulatory framework.

June 20, 2012 | Daily News

Lawmakers, brushing aside concerns from a major medical device trade group, included in the final FDA user fee bill a provision requiring FDA to notify Congress 60 days before issuing guidance regulating laboratory developed tests.

June 20, 2012 | Daily News

The device provisions in the final FDA user fee bill are getting mixed reactions from industry and consumer safety advocates with both applauding the timeline for issuance of a Unique Device Identifier rule and addition of devices to FDA's Sentinel initiative, but raising competing concerns about FDA's new flexibility to reclassify devices.

June 11, 2012 | Daily News

CMS Deputy Administrator for Program Integrity Peter Budetti said CMS is “looking at the restructuring of our entire [Medicaid] audit program so that we can use those resources in a much more effective way,” as House members slammed CMS over the handling of its contractor-run audit programs in hearings by two committees Thursday (June 7) and Friday (June 8).

June 07, 2012 | Daily News

Industry and lawmakers are turning their attention to the Senate following House passage Thursday (June 7) of a bill repealing the health reform-created medical device tax. Despite opposition to the bill from Senate leadership and a veto threat from the president, the medical device industry said it will continue its push for repeal in the upper chamber.

June 07, 2012 | Daily News

Rep. Ed Markey (D-MA) is calling on HHS Secretary Kathleen Sebelius to provide a detailed account of how the impending budget sequester will be applied to department programs and how the funding cuts will affect medical research and development, access to new medical treatments and other HHS programs.

June 06, 2012 | Daily News

Pennsylvania Congressman Jason Altmire, the lead Democrat on the medical device tax repeal legislation slated for a floor vote Thursday (June 7), tells Inside Health Policy that some Democrats who would like to vote for the tax repeal will vote against it because of how it's paid for, but he did not know how many fall into that category.

June 05, 2012 | Daily News

House GOP leadership officially decided to use recaptured health reform subsidy overpayments as the offset for legislation that would repeal the health law's medical device tax and the ban on purchasing non-prescribed over the counter drugs with tax-free accounts, and would also tweak the usage of flexible spending and health savings accounts.

June 04, 2012 | Daily News

The White House on Monday (June 4) hosted a summit on prioritizing standards to support electronic patient access to health data, Inside Health Policy has learned.

June 04, 2012 | Daily News

The Advancing Patient Safety Coalition is pushing lawmakers to include the Senate's more stringent language outlining the implementation of the Unique Device Identifier rule when they merge the House and Senate FDA user fee bills.

June 04, 2012 | Daily News

An FDA official said although the agency is not ready to create the kind of track and trace system for medical devices as stakeholders are currently developing for pharmaceuticals, there is a possibility that devices could be required to have serial numbers in the future.

June 02, 2012 | Daily News

Reps. Erik Paulsen (R-MN) and Jason Altmire (D-PA) told members of the medical device industry on Friday (June 1) that a measure to repeal the health reform-created medical device tax could be tacked onto larger tax reform measures that may be addressed at the end of the year, and offsets could come from outside the healthcare sector, although recapturing health reform subsidies or finding other pay fors within the health care law are still the most likely scenario.

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