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Medical Devices

September 08, 2017 | Daily News

President Donald Trump's regulatory czar directed agencies on Thursday (Sept. 7) to cap their regulatory costs for fiscal 2018, and indicated the Office of Management and Budget expects each agency to propose a net reduction in regulatory costs.

September 08, 2017 | Daily News

FDA plans to unveil a new Strategic Policy Roadmap outlining the agency's policy priorities, one of which will be rolling out new pre-clinical science policies aimed at streamlining the investigational new drug and biologics license application filing processes, Commissioner Scott Gottlieb told a diverse group of patient advocates, members of the drug and device industry, medical experts and other stakeholders during Research!America’s 2017 National Health Research Forum on Thursday (Sept. 7).

September 07, 2017 | Daily News

FDA is asking stakeholders to suggest regulations they feel should be cut pursuant to President Donald Trump's deregulatory executive orders.

September 06, 2017 | Daily News

FDA announced Wednesday (Sept. 6) it is hiring Entrepreneurs-In-Residence with backgrounds in software design, business process modeling, clinical trial design and investment to help develop the agency's Software Precertification (PreCert) Pilot Program -- including identifying reliable predictors of product quality, and developing data collection models.

September 05, 2017 | Daily News

The Clinical Decision Support Coalition, in an effort to self-regulate to avoid future FDA regulation of certain CDS software, released Wednesday (Aug. 30) final guidelines on what added software validation is needed for medium risk CDS software.

August 29, 2017 | Daily News

Despite glowing praise from industry, public health and consumer advocates are lukewarm over the action FDA has taken during Scott Gottleib's first 100 days as FDA commissioner -- holding up several recent product decisions they view as troublesome.

August 28, 2017 | Daily News

FDA has provided commissioned corps officers as part of the overall HHS deployment of medical equipment and resources to help address public health needs and assess critical health infrastructure needs in the wake of Hurricane Harvey.

August 24, 2017 | Daily News

In the wake of President Donald Trump's push toward deregulation, one regulatory policy watcher tells Inside Health Policy that the Scott Gottlieb-led FDA may be implementing a new regulatory paradigm centered more on individual regulatory decisions as opposed to formal rulemaking -- highlighting the agency's newly announced tobacco plan as one example.

August 21, 2017 | Daily News

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.

August 18, 2017 | Daily News

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

August 16, 2017 | Daily News

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.

August 14, 2017 | Daily News

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

August 11, 2017 | Daily News

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.

August 04, 2017 | Daily News

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.

August 03, 2017 | Daily News

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

August 01, 2017 | Daily News

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.

August 01, 2017 | Daily News

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.

August 01, 2017 | Daily News

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.

August 01, 2017 | Daily News

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.

July 28, 2017 | Daily News

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.