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Medical Devices

Wednesday, 21 June 2017

Republican leadership has indicated the Senate's health reform bill will contain language repealing the ACA's medical device tax, a medical technology lobbyist tells Inside Health Policy.

Thursday, 15 June 2017

FDA Commissioner Scott Gottlieb announced Thursday (June 15) that the agency plans to pilot an entirely new approach for regulating digital health tools, such as mobile apps and fitness trackers.

Wednesday, 07 June 2017

The House Energy & Commerce Committee sent its user fee package to the floor, 54-0, Wednesday (June 7), tacking on several new amendments that deal with medical imaging, device servicing, accessory classification, a medical device safety pilot program and a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs.

Wednesday, 07 June 2017

The House Energy & Commerce Committee attached a watered-down version of Rep. Ryan Costello's (R-PA) medical device imaging servicers bill to FDA user fee legislation Wednesday (May 7).

Wednesday, 07 June 2017

Drug importation from Canada, a sense of Congress on drug pricing and off-label communication with payers are the subjects of hot-button amendments that lawmakers signaled they plan to bring up at today's House Energy & Commerce markup of FDA user fee legislation.

Tuesday, 06 June 2017

On the eve of the House Energy & Commerce Committee's Wednesday (June 7) FDA user fee markup, health subcommittee member Rep. Diana DeGette (D-CO) spoke out publicly against GOP attempts to add controversial off-label amendments to the user fee reauthorization package.

Monday, 05 June 2017

FDA is extending the compliance date for when low-risk devices must bear a unique device identifier, as the agency mulls how to deal with existing challenges associated with data already being captured for higher risk devices, according to a letter released by the agency Monday (June 5).

Friday, 02 June 2017

The House Energy & Commerce Committee has tentatively scheduled markup of FDA user fee legislation for Wednesday (June 7), as talks continue on potential riders, including off-label amendments that Democrats have warned could derail their support for what so far has been a bipartisan user fee reauthorization effort.

Friday, 02 June 2017

The Washington Legal Foundation is urging FDA to withdraw and revise its highly disputed intended use rule, alleging the rule violates the First Amendment, “flunks” the Administrative Procedure Act and inappropriately inserts FDA into the practice of medicine.

Wednesday, 31 May 2017

FDA guidance is “not enough” to mitigate security risks, according to a new survey of medical device manufacturers and healthcare delivery organizations (HDOs).

Tuesday, 30 May 2017

FDA Commissioner Scott Gottlieb has hired two congressional veterans to serve as his senior advisers, Inside Health Policy has learned.

Thursday, 25 May 2017

FDA is no longer under a hiring freeze and will soon institute a rapid process for filling vacant positions, FDA Commissioner Scott Gottlieb wrote to agency staff in an internal memo Thursday (May 25).

Tuesday, 23 May 2017

President Donald Trump's fiscal 2018 budget proposal would cut FDA's human drug program by $307 million in discretionary budget authority, its medical device program by $182 million, its biologics program by $119 million and its food program by $70 million, resulting in cuts to the agency's workforce and programs even if Congress were to go along with Trump's request to double user fees.

Monday, 22 May 2017

President Donald Trump's fiscal 2018 budget proposes cutting FDA's discretionary budget authority by $854 million -- a shortfall that Trump says would be made up if lawmakers agree to his request to double user fees, despite the fact lawmakers on both sides of the aisle have to date rejected that proposal.

Monday, 22 May 2017

President Donald Trump's fiscal 2018 budget proposes cutting FDA's discretionary budget authority by $854 million -- a shortfall that Trump says would be made up if lawmakers agree to his request to double user fees, despite the fact lawmakers on both sides of the aisle have to date rejected that proposal.

Monday, 22 May 2017

Trump administration officials met with medical device lobbyists earlier this month to discuss a draft rule dubbed “ExCITe” that would expedite coverage of innovative technology, and briefing materials from the meeting include an industry proposal that CMS provisionally cover certain medical devices and diagnostics following FDA approval while the manufacturer continues to collect additional data on the technology.

Friday, 19 May 2017

FDA is working closely with medical device manufacturers and other government departments to address any devices that may have been compromised by the WannaCry cyberattack, FDA spokesperson Stephanie Caccomo told Inside Health Policy.

Friday, 19 May 2017

GAITHERSBURG, MD -- HHS has kicked off a new public-private initiative to develop cybersecurity standards for the health sector, aimed at aligning a number of cybersecurity frameworks and standards into a comprehensive package developed by government and industry.

Thursday, 18 May 2017

A House subcommittee easily passed FDA user fee legislation Thursday (May 18) with riders allowing over-the-counter hearings aids, requiring risk-based device inspections, offering new exclusivity for a new class of competitive generic drugs and restricting drug imports, and in the process brushed off the Trump administration's call for a doubling of the user fee levels FDA negotiated with industry.

Thursday, 18 May 2017

House Energy & Commerce health subcommittee lawmakers provided a preview Thursday (May 18) of legislation that could be added to user fee reauthorization either during the full committee markup or when the legislation hits the floor, including bills related to off-label communication, pediatric cancer research, orphan drug exclusivity, regulation of medical device servicers and over-the-counter monograph reform.

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