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Medical Devices

Tuesday, 21 March 2017

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.

Tuesday, 21 March 2017

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.

Friday, 17 March 2017

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.

Friday, 17 March 2017

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.

Thursday, 16 March 2017

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.

Thursday, 16 March 2017

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.

Thursday, 16 March 2017

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.

Friday, 10 March 2017

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.

Monday, 06 March 2017

The medical device tax would be permanently repealed in House GOP leaders' plan to overhaul the Affordable Care Act.

Friday, 03 March 2017

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.

Monday, 27 February 2017

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.

Tuesday, 14 February 2017

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.

Monday, 13 February 2017

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.

Wednesday, 08 February 2017

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.

Monday, 06 February 2017

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.

Friday, 03 February 2017

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.”

Wednesday, 01 February 2017

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.

Wednesday, 01 February 2017

Senate Finance Committee Chair Orrin Hatch (R-UT) said Wednesday (Feb. 1) that the ACA's taxes must be wrapped into the initial repeal bill, adding an influential voice to one of the largest questions that has split the GOP as they move to repeal and replace the Affordable Care Act.

Monday, 30 January 2017

House Energy & Commerce Democrats on Monday (Jan. 30) asked President Donald Trump to provide details on whether FDA user fee programs will be exempted from the federal hiring the White House announced Jan. 23.

Monday, 30 January 2017

President Donald Trump on Monday (Jan. 30) signed an executive order declaring for every new regulation introduced, two must be eliminated in a bid to cut regulations by up to 75 percent, and said any new regulatory burdens must be offset by other deregulatory policies so there are no new regulatory dollars spent during the remainder of fiscal 2017.

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