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Medical Devices

March 28, 2017 | Daily News

Lawmakers and stakeholders highlighted the successes of the medical device user fee program in speeding up FDA's review of devices, during a Tuesday (March 28) House Energy & Commerce hearing on reauthorization of the Medical Device User Fee Amendments (MDUFA).

March 28, 2017 | Daily News

The Trump administration is proposing a $40 million cut in FDA appropriations for the remainder of fiscal 2017, driven primarily by reductions in staffing, according to a document obtained by Inside Washington Publishers, which was recently sent to congressional appropriators.

March 28, 2017 | Daily News

A House Energy & Commerce Republican is pushing legislation that would give drug and device makers more leeway to discuss off-label information with the scientific community by exempting scientific exchange from intended use determinations, coming after FDA delayed for a year an intended use rule finalized in the last days of the Obama administration.

March 21, 2017 | Daily News

Recent calls from the medical device industry for Congress to push a risk-based framework for regulating laboratory developed tests (LDTs) appear to be answered by a new bipartisan draft bill that would give FDA authority over design, development, validation and production of in-vitro clinical tests (IVCTs), including LDTs, while retaining CMS' jurisdiction over laboratory operations.

March 21, 2017 | Daily News

A week after the president took stakeholders by surprise by proposing industry fully pay for FDA premarket reviews by doubling up on user fees, the White House plan was barely mentioned as Senate health committee Chairman Lamar Alexander (R-TN) launched hearings Tuesday (March 21) on user fee pacts penned by the Obama administration and industry.

March 17, 2017 | Daily News

FDA has put on hold until next March a controversial tobacco “intended use” rule that sparked controversy due to a last-minute addition that industry said posed extensive liability issues for drug and device manufacturers.

March 17, 2017 | Daily News

FDA has put on hold until next March a controversial tobacco “intended use” rule that sparked controversy due to a last-minute addition that industry said posed extensive liability issues for drug and device manufacturers.

March 16, 2017 | Daily News

President Donald Trump's budget blueprint sparked concerns among multiple stakeholders and legislators Thursday (March 16) for putting stable appropriations funding and already-negotiated FDA user fee agreements at risk.

March 16, 2017 | Daily News

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

March 16, 2017 | Daily News

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

March 10, 2017 | Daily News

President Donald Trump has delivered on his promise to shake up FDA by nominating American Enterprise Institute resident fellow and agency veteran Scott Gottlieb to serve as FDA commissioner.

March 06, 2017 | Daily News

The medical device tax would be permanently repealed in House GOP leaders' plan to overhaul the Affordable Care Act.

March 03, 2017 | Daily News

The Advanced Medical Technology Association (AdvaMed) is calling for Congress to craft a risk-based framework to regulate laboratory developed tests (LDTs) and in vitro diagnostics (IVDs), laying out its request in a March 3 letter to the heads of the House Energy & Commerce and Senate health committees.

February 27, 2017 | Daily News

FDA is working closely with Sen. Johnny Isakson (R-GA) on a bipartisan bill that would mandate a risk-based device inspection approach that factors in foreign audits, standardize pre-inspection communications, and ease the process for granting U.S device makers export certificates, a spokesperson for Isakson told Inside Health Policy.

February 14, 2017 | Daily News

Congress' investigative arm is pressing FDA to improve its surveillance of marketed medical devices, pointing to problems that led the agency to warn against use of laparoscopic power morcellators in minimally invasive surgeries.

February 13, 2017 | Daily News

The Advanced Medical Technology Association (AdvaMed) has a full-court press underway to convince lawmakers to repeal the Affordable Care Act's medical device tax as part of the upcoming reconciliation bill, identifying the issue as the trade group's number one priority.

February 08, 2017 | Daily News

CMS has temporarily delayed the next steps in setting up a consolidated round of durable medical equipment competitive bidding in 2019 in order to allow the new administration a “further opportunity to review the program,” the agency's website says.

February 06, 2017 | Daily News

Snagged by the Trump administration's regulatory freeze is a highly controversial FDA rule issued in the final days of the Obama administration that the regulation's critics say was a back-door attempt to increase drug and device makers' off-label liability under the guise of a tobacco intended use rule.

February 03, 2017 | Daily News

Despite Republican threats to overturn any regulations finalized before President Donald Trump took office, and swift actions by the newly minted president to stop agencies from issuing further regulations, FDA released over 70 guidances and multiple rules since the November election, with over 20 guidances coming since Trump took office, prompting one key Republican senator to begin reviewing what he called FDA's “last-minute midnight rulemaking.”

February 01, 2017 | Daily News

A key standards organization has recommended incorporation of unique device identifiers (UDIs) in claims forms for high-risk implantable devices, which FDA has pegged as a key step towards an active device surveillance system.

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