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Medical Devices

Monday, 21 August 2017

Durable medical equipment suppliers say legislation to provide “long-term relief” from Medicare pay cuts for suppliers in rural and non-competitive bid areas as well as address fee schedule cuts for stationary oxygen and allow an exemption from competitive bidding for accessories for manual complex rehabilitation technology could be introduced when lawmakers return from August recess.

Friday, 18 August 2017

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

Wednesday, 16 August 2017

A coalition of critical industry groups and technology companies is defending HHS' recent decision to establish a cyber-threat information sharing center, arguing the group would augment rather than duplicate info-sharing efforts by the Department of Homeland Security.

Monday, 14 August 2017

FDA issued guidance that stretches out the deadlines for certain tobacco deeming rule pre-market review compliance requirements.

Friday, 11 August 2017

FDA formalized Wednesday (Aug. 9) a program allowing sponsors to get certification of Medical Device Development Tools (MDDT) used for product research and evaluation, which the agency hopes will speed medical device development.

Friday, 04 August 2017

Senate Finance Committee members Mark Warner (D-VA) and Johnny Isakson (R-GA) introduced legislation on Thursday (Aug. 3) to create a temporary reimbursement structure for Medicare home infusion services, known as the Medicare Home Infusion Therapy Access Act of 2017.

Thursday, 03 August 2017

The Senate passed 94-1 Thursday (Aug. 3) the FDA Reauthorization Act, sending the user fee legislation to the president’s desk.

Tuesday, 01 August 2017

Senate Majority Leader Mitch McConnell (R-KY) announced Tuesday (August 1) that Republicans want to vote on the FDA user fee package before the August recess, but one industry source tells Inside Health Policy that while Republicans want to move on the legislation next week, Democratic and Republican leadership have not yet agreed on an amendment package.

Tuesday, 01 August 2017

Senate Majority Leader Mitch McConnell (R-KY) filed cloture late Tuesday (August 1) on the motion to proceed with the FDA user fee package, setting up a Senate vote on the motion early Thursday.

Tuesday, 01 August 2017

FDA and its advisers are struggling to decipher whether Congress' definition of real-world evidence excludes data gathered as part of a single-arm trial as they move forward on a 21st Century Cures work plan that calls for studying the use of RWE for new drug indications and post-approval studies.

Tuesday, 01 August 2017

FDA and the Duke-Margolis Center For Health Policy will hold a public meeting in September to gather input on opportunities and challenges for using real-world evidence to support approval of a new indication and to help satisfy post-approval study requirements, according to an agency notice.

Friday, 28 July 2017

FDA's announcement that it will develop a comprehensive nicotine regulatory plan, further extend compliance deadlines for its tobacco deeming rule, seek input from the public about how to lower nicotine levels in combustible cigarettes, and issue product guidance and standards drew mixed reactions from advocacy organizations, academics and stakeholders.

Friday, 28 July 2017

FDA's announcement that it will further extend compliance deadlines for its tobacco deeming rule, as part of its comprehensive tobacco and nicotine regulatory plan, drew criticism from a former FDA official and advocacy organizations.

Thursday, 27 July 2017

FDA launched a pre-certification pilot program Thursday (July 27) that will allow technology and software development companies to get pre-certified with the agency, eventually allowing them to “submit less information [to FDA] than is currently required before marketing a new digital health tool,” FDA Commissioner Scott Gottlieb says.

Tuesday, 25 July 2017

The so-called skinny-repeal bill that Senate Republicans are considering includes the repeal of just one Affordable Care Act tax, the medical device tax, which is also the sole tax up for repeal in legislation that Sens. Lindsey Graham (R-SC) and Bill Cassidy (R-LA) are pushing.

Monday, 24 July 2017

FDA Commissioner Scott Gottlieb wrote to FDA staff Monday (July 24) that the agency will not issue layoff notices to user fee-funded employees until Sept. 30, buoyed by confidence that the user fee package will be signed into law before the existing authorizations lapse.

Tuesday, 18 July 2017

Former Sidley Austin partner and product liability specialist Rebecca Wood has been named FDA chief legal counsel.

Tuesday, 18 July 2017

The Senate Appropriations agriculture subcommittee advanced its fiscal 2018 FDA funding bill Tuesday (July 18), paving the way for full committee consideration Thursday (July 20).

Wednesday, 12 July 2017

The House passed FDA user fee legislation Wednesday afternoon (July 12) by voice vote, and lawmakers pressed the Senate to act quickly on the must-pass reauthorization package to avoid pink slips being sent to FDA employees at the end of the month.

Monday, 10 July 2017

A revised FDA user fee package set to face a House vote Wednesday afternoon under suspension of the rules largely combines the marked up House and Senate bills, and leaves out legislation crafted by industry and FDA to create an over-the-counter monograph user fee program.

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