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Medical Devices

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.

September 13, 2012 | Daily News

David Dorsey, FDA's acting associate commissioner for policy and planning, is leaving the agency to become a senior director at Janssen Research and Development, according to a memo Commissioner Margaret Hamburg sent to agency staff Wednesday (Sept. 12).

September 12, 2012 | Daily News

A CMS advisory panel will discuss whether positron emission tomography imaging could be used to manage Alzheimer's at a meeting slated for Jan. 30, which will occur just two weeks after the agency is expected to decide whether to reverse its policy of not covering PET for any disease.

September 11, 2012 | Daily News

FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10).

September 06, 2012 | Daily News

GOP presidential candidate Mitt Romney cited both FDA's “slow and opaque” approval process and the health reform-created medical device tax as policies that are impeding medical innovation, including development of new medical countermeasures, antibiotics and vaccines, in response to a series of questions posed to both presidential candidates on science policy by a group of leading science organizations.

September 05, 2012 | Daily News

The Federal Trade Commission is telling mobile application developers to tell the truth about what their app can do, including showing competent and reliable scientific evidence about health claims, in a new guide designed to help developers observe truth-in-advertising and basic privacy principles when marketing new mobile apps.

September 04, 2012 | Daily News

Mandatory across-the-board government funding cuts might apply to FDA user fees and as a result lead to a bigger agency impact that initially thought, FDA funding advocates said in advance of an administration report set for release this week that will detail cuts to occur under the budget act's sequestration.

August 28, 2012 | Daily News

Republicans are targeting reform of FDA to foster innovation in the drug and medical device sectors as part of the party's platform set to be unveiled at the GOP convention this week, with a draft version of the platform saying a lack of predictability, consistency, transparency and efficiency at the agency is driving companies overseas.

August 24, 2012 | Daily News

The U.S. Court of Appeals for the District of Columbia Circuit on Friday (Aug. 24) blocked FDA's attempt to implement cigarette warning label requirements, teeing up a potential for Supreme Court review as Friday's ruling conflicts with a different appeals court decision, according to several groups pressuring the government to continue defending the labels.

August 24, 2012 | Daily News

Clinical laboratories met recently with the White House Office of Management and Budget to reassert their call for CMS oversight of laboratory-developed tests to avert FDA regulatory controls expected to be outlined in a forthcoming guidance document.

August 21, 2012 | Daily News

New draft guidance outlining FDA's refuse to accept policy for 510(k) medical device submissions could lead the agency to invoke its authority to block incomplete applications more frequently and encourage companies to submit more complete submissions, a change that could speed up review times, industry attorneys said following release of the user fee-mandated guidance.

August 16, 2012 | Daily News

A duo of Democratic lawmakers and the backers of device predicate nullification measures during debate around the FDA Safety and Innovation Act, pressed FDA to make changes to its 510(k) device database that would provide more information about products recalled for serious design flaws, saying the updates could help manufacturers avoid using recalled devices as predicates.

August 15, 2012 | Daily News

CMS announced on Monday (August 13) that it is immediately discontinuing a hospital quality reporting measure used in determining whether hospitals properly care for heart-attack patients after FDA recalled devices that many hospitals were using to monitor compliance with the measure.

August 02, 2012 | Daily News

CMS plans to launch a controversial power wheelchair prior authorization demonstration on Sept. 1 in seven states, the agency announced Wednesday (Aug. 1), and some industry stakeholders say that the revamped program, which is less expansive than an earlier version which was originally delayed due to provider and lawmakers' concerns, may still jeopardize beneficiary access to power wheelchairs.

August 01, 2012 | Daily News

A group of 23 high-profile health policy experts on Wednesday (Aug. 1) floated far-reaching proposals to cut back health care spending that include moving to a system that would allow states to promote payment rates within a global spending target, requiring exchanges to be active purchasers and to offer at least one “tiered” product, using competitive bidding for all commodities in the federal health system and the insurance exchange, expanding the ban of self-referrals to cover private insurers, requiring full price transparency and encouraging less restrictive state scope of practice laws.

August 01, 2012 | Daily News

CMS Deputy Administrator for Program Integrity Peter Budetti says the agency's new anti-fraud Command Center will pay for itself many times over, despite Senate Finance Committee Republicans' concerns that the agency's new predictive analytics hub, which pulls together all aspects of the agency's program integrity efforts, may not be necessary.

July 31, 2012 | Daily News

Emergency care groups applauded the National Institutes of Health for creating a new office for emergency care research and said the office, unveiled Tuesday (July 31) following years of discussions with stakeholders, was a significant advance for emergency medicine investigators and emergency patients.

July 24, 2012 | Daily News

Community pharmacists warned CMS on Monday that they might stop selling retail diabetic testing supplies if the agency follows through on a plan to bring Medicare reimbursement for such supplies in line with lower mail-order prices using a controversial and rarely used “inherent reasonableness” tool, but agency officials said the cuts would occur soon regardless of whether that tool is used or retail supplies are instead put into the competitive bidding program.