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Medical Devices

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.

Monday, 30 January 2017

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.

Friday, 27 January 2017

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).

Friday, 27 January 2017

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.

Tuesday, 24 January 2017

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.

Tuesday, 24 January 2017

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.

Tuesday, 17 January 2017

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.

Friday, 13 January 2017

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.

Thursday, 12 January 2017

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

Wednesday, 11 January 2017

CMS proposed pay provisions and requirements for those providing and fabricating prosthetics and custom-made orthotics on Wednesday (Jan. 11), and included a provision that suppliers not meeting the requirements once the rule is finalized could have their Medicare enrollment revoked.

Tuesday, 03 January 2017

As congressional Republicans began charting a course to repeal the Affordable Care Act, a bipartisan group of 220 House members introduced a bill Tuesday (Dec. 3) to repeal the law's medical device excise tax, which was suspended for two years on Dec. 31, 2015.

Wednesday, 28 December 2016

The HHS Office of Inspector General has updated its investigation into how FDA ensures the cyberscurity of networked medical devices before they hit the market, and hopes to release its findings by next fall or winter, HHS OIG spokesperson Donald White said.