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Medical Devices

February 13, 2019 | Daily News

A bipartisan group of eight House lawmakers is seeking support for a bill to permanently repeal the Affordable Care Act's 2.3 percent excise tax on medical devices.

February 08, 2019 | Daily News

Device industry lawyers believe FDA’s move toward allowing use of objective performance criteria to evaluate certain new medical devices, rather than relying on predicate devices, could improve the agency’s 510(k) process by creating a more streamlined pathway for well-understood devices.

February 06, 2019 | Daily News

Despite warnings from the medical device industry that FDA would be slammed by a backlog of medical product applications that piled up during the shutdown, a former FDA advisory told Inside Health Policy the agency’s user fee-funded activities should return to normal operations and workload shortly.

February 05, 2019 | Daily News

In keeping with the goals of the 21st Century Cures Act, FDA on Tuesday (Feb. 5) published draft guidance aimed at laying out predictable premarket review pathways for combination products.

February 04, 2019 | Daily News

In final guidance released Monday (Feb. 4), FDA lays out how it will apply least burdensome provisions of medical device review to a device’s total product lifecycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards.

February 04, 2019 | Daily News

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

January 31, 2019 | Daily News

Experts in the antibiotic and medical device industries say FDA’s recent guidance for device and antibiotic makers on how to coordinate antibiotic susceptibility test (AST) development addresses a niche problem that should encourage more interest in antibiotic development.

January 30, 2019 | Daily News

An official in FDA’s medical device center announced the agency has launched a new project intended to encourage device stakeholders to partner with cybersecurity researchers -- also called white hat hackers -- as a means of boosting the resilience, transparency and trustworthiness of medical devices and the health care system overall.

January 29, 2019 | Daily News

An FDA official on Tuesday (Jan. 29) told a group of stakeholders that legacy medical devices remain an “intractable challenge” for promoting cybersecurity in the medical device space, a view also held by agency chief Scott Gottlieb who, on the same day, stated that one of FDA’s most critical challenges lies in addressing safety risks posed by the devices.

January 28, 2019 | Daily News

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

January 24, 2019 | Daily News

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

January 23, 2019 | Daily News

FDA just took two steps toward realizing a controversial plan that would change parts of the 510(k) process: introducing objective performance criteria and encouraging medical device makers to use younger predicates in their applications.

January 18, 2019 | Daily News

FDA released final guidance on Thursday (Jan. 17) that the agency says will encourage the development of antimicrobial susceptibility tests (ASTs) to help determine whether a pathogen will likely respond to, or has developed resistance to, certain antimicrobial drugs.

January 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

January 10, 2019 | Daily News

Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement pre-cert?

January 09, 2019 | Daily News

CMS says in recently released guidance that states do not need to obtain a Medicare denial for certain durable medical equipment coverage before Medicaid, which acts as a secondary payer for those dually eligible for Medicare and Medicaid, can pay for the equipment.

January 08, 2019 | Daily News

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework.

January 07, 2019 | Daily News

Medical device experts say that crafting new regulatory frameworks for laboratory developed tests (LDTs), digital health apps and medical device cybersecurity are among the top FDA-related issues they will be tracking in 2019.

January 04, 2019 | Daily News

Greg Garcia, executive director for cybersecurity of the Healthcare and Public Health Sector Coordinating Council, says the group will be gearing up over the next few weeks to encourage widespread adoption of recently issued cybersecurity guidelines, as it also develops a process for measuring the effectiveness of the voluntary guidance for reducing cyber risks for hospitals, patients and the rest of the medical community.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.