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Medical Devices

September 11, 2018 | Daily News

Device industry and cybersecurity lawyers plan to soon unveil an in-depth report describing a pathway for medical device manufacturers and the wider health care sector to protect against cybersecurity threats.

September 10, 2018 | Daily News

The House on Wednesday (Sept. 12) is set to consider, likely under suspension of the rules, several bills passed by the Ways & Means Committee last week, including legislation to make CMS' Local Coverage Decision process more transparent and to direct HHS to finish updating regulations for the Programs of All-Inclusive Care for the Elderly, according to House Majority Leader Kevin McCarthy's (R-CA) weekly schedule.

September 06, 2018 | Daily News

FDA has launched a new pilot program intended to make the premarket submission process for medical devices more efficient by allowing applicants to use electronic forms to structure their submissions.

September 06, 2018 | Daily News

The House Ways & Means Committee passed a tweaked version of a bill backed by the medical device industry to clarify and make CMS' local coverage determination process more transparent.

September 06, 2018 | Daily News

The House Ways & Means Committee passed a tweaked version of a bill backed by the medical device industry to clarify and make CMS' local coverage determination process more transparent.

September 05, 2018 | Daily News

The House Ways & Means Committee passed four bipartisan health care bills on Wednesday (Sept. 5) -- which would test the use of smart cards to stem fraud, codify a Medicare enrollment fix, require final regulations for the Programs of All-Inclusive Care for the Elderly program and tweak the local coverage determination process -- but some Democrats complained the measures deal with problems on the periphery of Medicare and the health care system.

August 31, 2018 | Daily News

A guidance policy issued by the Department of Justice (DOJ) in November 2017 and then reiterated in a DOJ memo in January has provided industry lawyers a potential new tool to fight FDA enforcement action brought against a company using guidance documents as the basis for enforcement.

August 24, 2018 | Daily News

The American Clinical Laboratory Association (ACLA) and AdvaMedDx are raising concerns with a draft legislative proposal floated by FDA on Aug. 6 that would overhaul federal regulation of diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs). ACLA asks lawmakers to reject the proposal in its entirety, while AdvaMedDx calls for more discussion on the plan.

August 17, 2018 | Daily News

An industry lawyer said FDA’s recent technical assistance (TA) on a diagnostics regulation reform bill does far more than provide technical comments, and instead proposes an entirely new legislative framework that would shake up the agency’s 42-year-old diagnostic premarket review process.

August 16, 2018 | Daily News

An industry lawyer said a newly proposed list of device accessories that FDA thinks could be re-classified as low-risk does not fully embrace requests from industry and a directive from Congress to reduce the regulatory burden related to certain device accessories.

August 14, 2018 | Daily News

Home health providers question how CMS' revamped home health demonstration will help stem fraud when the agency has recognized the high improper pay rate in that sector appears to be driven largely by paperwork problems, and suggest CMS look at alternatives.

August 10, 2018 | Daily News

Women's health experts are skeptical of a newly FDA-approved mobile medical app that keeps track of women's menstrual cycles as a method of contraception.

August 09, 2018 | Daily News

Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review.

August 09, 2018 | Daily News

Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency's authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA's new, voluntary precertification pathway.

August 08, 2018 | Daily News

A spokesman for the Advanced Medical Technology Association (AdvaMed) said his organization is reaching out to Colorado voters through local radio, television, print and online networks in a bid to pressure Sen. Michael Bennett (CO) to become the medical device tax-repeal bill’s tenth Democratic cosponsor in the Senate.

August 07, 2018 | Daily News

Senators looking at how to reduce administrative costs in the health system were encouraged by a Harvard professor to consider pushing for more standardized prior authorization procedures, aspects of which were backed by doctors and hospitals as part of a consensus statement released earlier this year along with the insurance lobby and BlueCross BlueShield Association.

August 03, 2018 | Daily News

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation.

August 03, 2018 | Daily News

FDA this week notified seven device manufacturers that their products are being inappropriately marketed for unapproved “vaginal rejuvenation” procedures, such as treating conditions and symptoms related to menopause, urinary incontinence or sexual function.

July 31, 2018 | Daily News

Fearing Chinese retaliatory tariffs and the ensuing price hikes, medical device manufacturers urged U.S. States Trade Representative (USTR) Robert Lighthizer to remove medical devices and technology from a proposed list of goods for which an additional 25 percent tariff would be imposed.

July 26, 2018 | Daily News

Pacific Research Institute released a report critiquing CMS' competitive bidding program for durable medical equipment shortly after the agency proposed a rule putting the program on hold as it makes changes that are viewed by suppliers as the strongest examples to date of the agency taking their concerns into account.