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Medical Devices

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The medical device tax would be permanently repealed in House GOP leaders' plan to overhaul the Affordable Care Act.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

February 01, 2017 | Daily News

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.

January 30, 2017 | Daily News

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.

January 30, 2017 | Daily News

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.

January 30, 2017 | Daily News

Unexpected language tucked into an FDA tobacco rule on intended uses, put out in the final days of the Obama administration, is raising alarms among industry and lawmakers who worry the additions could expose companies to misbranding liability beyond tobacco products.

January 27, 2017 | Daily News

Over 30 disease advocacy groups wrote to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schemer (D-NY) Tuesday (Jan. 24) urging Congress to work with FDA to craft a regulatory framework for laboratory developed tests (LDTs).

January 27, 2017 | Daily News

A newly posted FDA webpage provides sponsors with information about what types of products will qualify for the controversial new Regenerative Advanced Therapy (RAT) approval pathway created by the 21st Century Cures law.

January 24, 2017 | Daily News

Self-described FDA law originalist Joseph Gulfo, who has been an outspoken advocate for cutting regulations and reforming FDA approval policies to speed market access, is rising to a top spot on President Donald Trump's list of potential FDA commissioners, a source in touch with the transition team tells Inside Health Policy.

January 24, 2017 | Daily News

President Donald Trump put heads of executive departments and agencies on notice that no new rules or guidances should be sent to the Office of the Federal Register (OFR) until a Trump-appointed or designated agency head reviews and approves them, potentially putting controversial FDA draft guidances and notices on such hot-button issues as off-label use, new dietary ingredients, compounding and biosimilars on hold.

January 17, 2017 | Daily News

Industry experts say FDA's newly issued rule clarifying when tobacco products should be regulated as drugs, devices or combination products includes new language on “intended uses” that could be perceived by industry as an attempt to push back on recent court decisions that truthful, non-misleading, off-label promotion is legal.

January 13, 2017 | Daily News

FDA released Friday (Jan. 13) a discussion paper outlining a possible approach to laboratory developed test (LDT) oversight that gives both CMS and FDA a place in regulating the tests, but applies a risk-based framework phased in over four years and grandfathers in previously marketed LDTs.

January 12, 2017 | Daily News

A key hospital lobby group is urging FDA to examine existing hospital reporting programs instead of trying to create a new system.