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Medical Devices

March 18, 2019 | Daily News

Several medical device industry lawyers say FDA guidance that outlines how companies can seek feedback on actions they propose to correct problems found during inspections puts industry in a quandary.

March 13, 2019 | Daily News

FDA’s device center announced on Wednesday (March 13) that it will launch its long-planned internal reorganization aimed at addressing the total life cycle of products on March 18 and, should all go as planned, complete the overhaul by Sept. 30, 2019.

March 13, 2019 | Daily News

As speculation of who could be confirmed to permanently replace FDA Commissioner Scott Gottlieb circulates among the media and stakeholders, consumer advocates say they would prefer someone who has fewer ties to industry while one industry consultant hopes the next commissioner will be an outsider who has familiarity with data and technology yet can still work within the guardrails of FDA.

March 12, 2019 | Daily News

CMS’ decision to add non-invasive ventilators to the revamped durable medical equipment competitive bidding program set to go into effect in 2021 has upset DME suppliers, with the DME lobby calling it a “terrifying development” for patients and saying the group will press the Trump administration and Congress to stop that addition.

March 12, 2019 | Daily News

National Cancer Institute Director Ned Sharples will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

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.

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