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Medical Devices

November 06, 2017 | Daily News

FDA is taking steps to modernize its organizational structure and improve coordination among its expert staff, as well as reconsidering its approach to risk-benefit assessment in pre- and postmarket drug reviews, especially in regards to opioids, FDA Commissioner Scott Gottlieb said at a National Press Club luncheon on Friday (Nov. 3).

October 25, 2017 | Daily News

FDA has qualified its first medical device development (MDDT) tool -- the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) patient-reported outcome (PRO) assessment -- through its voluntary MDDT program in which FDA determines, or qualifies, whether certain tools used by companies during device development and regulatory evaluation can measure what they are intended to measure.

October 24, 2017 | Daily News

Nearly 180 House lawmakers urged Speaker Paul Ryan (R-WI) in a letter Tuesday (Oct. 24) to work with the Ways & Means Committee to repeal the medical device tax, which is set to go back into effect in January 2018.

October 20, 2017 | Daily News

Approximately 50 critical medical devices are being monitored for risk of shortage due to Hurricanes Irma and Maria, FDA Commissioner Scott Gottlieb said Friday (Oct. 20).

September 29, 2017 | Daily News

FDA Commissioner Scott Gottlieb said the agency's new device pre-certification pilot program offers a “modern approach to regulation” that could be applied across the agency, including to laboratory-developed tests (LDTs).

September 29, 2017 | Daily News

FDA has selected nine major medical device and technology companies to be part of its Pre-Cert pilot program, including Apple, Fitbit, Johnson & Johnson, Samsung, Verily and Roche, agency chief Scott Gottlieb announced during the Advanced Medical Technology Association's MedTech Conference on Tuesday (Sept. 26).

September 18, 2017 | Daily News

FDA Commissioner Scott Gottlieb said that Congress should legislatively lay out the government's role in overseeing diagnostic tests, and that the broader diagnostic testing community should work together to understand how to commercialize tests so they better benefit patients.

September 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb said the agency will soon make more health-related data public, including data sets compiled by FDA, adverse event reports, and letters on Risk Evaluation and Mitigation Strategies (REMS).

September 11, 2017 | Daily News

FDA Commissioner Scott Gottlieb told stakeholder Monday (Sept. 11) he wants to see the agency more systematically review existing regulations.

September 11, 2017 | Daily News

Medicare will replace beneficiaries’ durable medical equipment wrecked by Hurricane Harvey without the typical documentation of doctor visits and physician orders, but only suppliers chosen by the DME bidding program may provide the equipment in certain areas.

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.