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Medical Devices

July 28, 2017 | Daily News

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.

July 27, 2017 | Daily News

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.

July 25, 2017 | Daily News

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.

July 24, 2017 | Daily News

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.

July 18, 2017 | Daily News

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

July 18, 2017 | Daily News

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).

July 12, 2017 | Daily News

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.

July 10, 2017 | Daily News

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.

July 07, 2017 | Daily News

In September FDA will unveil a comprehensive framework detailing how the agency plans to regulate and oversee regenerative medicine though a series of guidance documents aimed at streamlining agency policies to help manufacturers demonstrate safety and effectiveness, Commissioner Scott Gottlieb announced Friday (July 7).

July 07, 2017 | Daily News

FDA's final work plan for 21st Century Cures Innovation Account targets what the agency views as the highest priorities for enhancing patient access to therapies and information, including improving upon the Regenerative Medicine Advanced Therapy (RMAT) Designation and modernizing regulation of combination products.

July 07, 2017 | Daily News

A group of Democratic senators are pressing FDA Commissioner Scott Gottlieb for answers regarding what they view as an overly long process leading up to the recent recall of faulty lead detection tests -- namely, the senators want to know what additional authorities the agency needs to prevent a long lag time between identification of a safety issue and a recall in the future.

June 27, 2017 | Daily News

House appropriators are proposing to fund FDA at the same level in fiscal 2018 as the agency received this year, rejecting President Donald Trump's call to cut the agency's budget and ask industry to pay more in user fees.

June 21, 2017 | Daily News

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.

June 15, 2017 | Daily News

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.

June 07, 2017 | Daily News

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.

June 07, 2017 | Daily News

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).

June 07, 2017 | Daily News

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.

June 06, 2017 | Daily News

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.

June 05, 2017 | Daily News

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).

June 02, 2017 | Daily News

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.