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Medical Devices

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to accept” checklist agreed to during user fee negotiations, the medical device industry tells FDA in comments on draft guidance outlining the agency's policy in this area.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.

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.

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