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Medical Devices

March 07, 2019 | Daily News

The medical device lobby applauded a bill rolled out by a bipartisan duo of senators on Thursday (March 7) that would do away with the Affordable Care Act’s 2.3 percent excise tax on medical devices.

March 07, 2019 | Daily News

Medical device industry experts say FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.

March 06, 2019 | Daily News

A bipartisan House bill introduced last Thursday (Feb. 28) would give Medicare and Medicaid beneficiaries greater access to their health care records via mobile apps, supporting a proposed rule released by CMS in early February requiring some plans to test application programming interface (API) for health information and to make provider networks available via API.

March 05, 2019 | Daily News

FDA Commissioner Scott Gottlieb’s unexpected resignation leaves myriad agency policy and regulatory plans, many of which Gottlieb identified as key priorities, hanging in the balance.

March 05, 2019 | Daily News

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.

March 05, 2019 | Daily News

FDA Commissioner Scott Gottlieb announced Tuesday (March 5) he will leave the agency within the next month and touted his agency’s many accomplishments during his 23 months as chief in a resignation letter to HHS Secretary Alex Azar, but he didn’t say why he was resigning.

February 28, 2019 | Daily News

The medical device lobby applauded a bill that would let FDA collect new user fees during a lapse in agency funding, allowing the agency to continue reviewing device applications in the event of a future government shutdown.

February 26, 2019 | Daily News

Three federal health agencies are forming a task force to streamline and coordinate the government’s role in making diagnostic tests available during an emergency.

February 21, 2019 | Daily News

Officials from FDA’s device center say it is too early to answer many of industry’s questions about the agency’s nascent digital health software precertification program, including those asking what new authority FDA needs to implement the program.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

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.