Medical Devices

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.

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.

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.

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.

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.

The Advanced Medical Technology Association was delighted by a 283-132 vote in the House of Representatives Tuesday (July 24) to repeal the 2.3 percent excise tax on medical devices that had been included as a funding source for the Affordable Care Act. Scott Whitaker, the association’s president and CEO, called the vote a win for American innovation, jobs and patients, and urged the Senate to quickly pass the legislation.

House Majority Leader Kevin McCarthy (R-CA) on Thursday revealed plans to bring a permanent repeal of the medical device tax, a two-year delay of the health insurance tax, a reversal of the ACA's ban on using tax-preferred accounts for over-the-counter medicine and tweaks to health savings accounts (HSAs) to the floor next week, but sources say he doesn't plan a vote on legislation that would delay the 40 percent tax on high-cost plans (known as the Cadillac tax) or mitigate the employer mandate at this time.

FDA Commissioner Scott Gottlieb called for the creation of a national resource to coordinate the development and use of real-world evidence (RWE) in medical product development and regulatory science in a recent FDA Voice blog post.

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.