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Medical Devices

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.

May 31, 2012 | Daily News

A provision included in the Senate user fee bill that would allow FDA to more easily reclassify devices is emerging as a possible point of contention as Congress prepares to resolve differences between the user fee bills passed by both chambers, sources said.

May 31, 2012 | Daily News

Lawmakers must now resolve a wide range of discrepancies between House and Senate FDA user fee legislation that include differences in the generic drug pay-fors, drug track and trace language and several medical device provisions following the House's overwhelming passage of FDA user fee bill Wednesday.

May 30, 2012 | Daily News

As the House prepared to vote on FDA user fee legislation Wednesday afternoon, a key consumer advocacy group geared up to lobby lawmakers to endorse the Senate bill's stricter provisions on a handful of items when they merge the chambers' bills. Consumers Union is pushing for Senate-passed user fee language on medical device reclassification, Unique Device Identifier implementation and postmarket studies.

May 25, 2012 | Daily News

The House will vote as early as the week of June 4 on bills to repeal the health reform law's tax on medical devices and its ban on using HSAs and FSAs to purchase over-the-counter drugs, according to a May 25 internal memo from House Majority Leader Eric Cantor (R-VA).

May 24, 2012 | Daily News

The Senate Thursday (May 24) overwhelming passed the FDA user fee bill after rejecting highly controversial amendments aimed at limiting drug patent settlements and allowing certain drug imports from Canada. Stakeholders are now setting their sights on the House, which is expected to take up its version of the bill next week, followed by an informal conference to sort out the differences between the two bills.

May 24, 2012 | Daily News

Prior to voting in favor of FDA user fee legislation Thursday (May 24), the Senate took up nearly 20 amendments, with several passing by unanimous consent and the remainder either tabled, withdrawn or rejected. The following is a quick snapshot of the Senate votes leading up to final passage of the bill.

May 24, 2012 | Daily News

Senators on Thursday (May 24) morning voted down an amendment to the FDA user fee bill aimed at curbing drug patent settlements, rejecting by a wide margin a measure backed by a bipartisan duo of senators but that drew strong opposition from the generic drug industry. The upper chamber also rejected an amendment delaying FDA approval of genetically engineered fish to complete environmental and economic analysis, but approved by unanimous consent a handful of less controversial measures.

May 23, 2012 | Daily News

The Union of Concerned Scientists is already taking steps to recruit its own members to serve on FDA advisory committees in anticipation that regulated industry may try to increase its presence on the panels as a result of user fee provisions moving through Congress that lift caps on the number of conflicted experts that can participate. Consumer and safety advocates opposed lifting the caps, but were successful in adding provisions to the user fee bills that would require financial disclosure of these experts and increase recruitment efforts.

May 23, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) delayed proceeding with the FDA user fee bill again Wednesday (May 23) saying there is a dispute on a Republican amendment. Sources said the more than 30 amendments filed in recent days will be whittled down, with votes expected on Sen. John McCain's (R-AZ) amendment on drug reimportation and Sen. Jeff Bingaman's (D-NM) proposal to curb drug patent settlements, among a few others.

May 23, 2012 | Daily News

Senators from both sides of the aisle floated a slew of amendments ranging from a drug shortage critical reinforcement program to a repeal of the health reform-created medical device tax as concerns emerged that the upper chamber might not pass user fee legislation ahead of a week-long recess, with Senate leaders Tuesday afternoon delaying a motion to proceed and threatening to file cloture.

May 22, 2012 | Daily News

Updated Story

A urology physicians group is urging its members to reach out to lawmakers to make sure the government does not restrict Medicare and Medicaid access to prostate cancer screening, reacting to the U.S. Preventive Services Task Force's recommendation Monday (May 21) against use of the Prostate-Specific Antigen screening test for prostate cancer in healthy men. The Large Urology Group Practice Association charges that USPSTF “clearly 'cherry-picked' the data to support what can only be viewed as a pre-conceived bias against screening.”

May 21, 2012 | Daily News

CMS should update its coverage with evidence development (CED) policy to encourage drug and medical device makers to invent products that save Medicare money and improve the outcomes of clinical care, former CMS official Sean Tunis told the Medicare Evidence Development & Coverage Advisory Committee Wednesday (May 16). MEDCAC agreed that it is possible to use an “evidentiary threshold” to invoke CED, and Tunis recommended thresholds that tie into comparative effectiveness research.

May 18, 2012 | Daily News

Companies developing mobile medical applications, FDA and other stakeholders have come out against a last-minute addition to the Senate user fee bill that would require an outside working group report to Congress on a proposed regulatory framework for health information technologies before FDA could issue final mobile medical application guidance.

May 17, 2012 | Daily News

As FDA user fee bills head to the full House and Senate, consumer and safety advocates are focusing their lobbying efforts on convincing lawmakers to add provisions that would institute additional safeguards for implantable medical devices, including measures that would reduce the number of products cleared through the 510(k) process, while acknowledging that limiting the use of recalled devices as predicates for new device clearances is not likely to be included in user fee legislation. The groups are hopeful, however, that FDA might address predicate nullification administratively.

May 17, 2012 | Daily News

Senate Majority Leader Harry Reid (D-NV) is urging senators to be ready to quickly pass the FDA user fee legislation bill on Monday (May 21), warning that if he is forced to instead hold a cloture vote, debate on the bill could not begin until Wednesday (May 23). Reid encouraged senators to file amendments to the bill if they have problems with it, but not to hold up the legislation, citing the importance of the bill's drug shortage measures.

May 16, 2012 | Daily News

An updated Senate user fee bill unveiled late Tuesday adds provisions related to mobile medical applications guidance, rare diseases and patient participation in medical product discussions, with further changes expected in a manager's amendment before the legislation hits the Senate floor, a source close to the issue says. Senate Majority Leader Harry Reid (D-NV) said Tuesday that although he is lining the bill up for a cloture vote Thursday (May 17), he hopes to avoid a cloture vote and move directly to a floor vote Monday.

May 14, 2012 | Daily News

A measure included in the House user fee bill requiring FDA to notify Congress 60 days before issuing guidance regulating laboratory developed tests could provide the impetus needed to move a stand-alone bill expanding CMS oversight of these tests that the clinical laboratory industry was unable to get into the user fee package, an industry source said. However, the source said it is unlikely the last-minute House notification measure will wind up in the Senate user fee bill set to hit the floor soon and it will be up to conferees if the provision is part of the final legislation.

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