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Medical Devices

October 02, 2018 | Daily News

Medical device industry experts said that a draft guidance released by FDA last week aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies, and would help the agency achieve its goal of reducing its average 510(k) review times.

October 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced three new initiatives aimed at increasing cybersecurity preparedness and information-sharing among medical device stakeholders, particularly among health care delivery organizations (HDOs) such as hospitals.

September 28, 2018 | Daily News

The medical device industry may soon have more opportunities to use a faster premarket review program, thanks to proposals included in a draft FDA guidance that would expand the agency’s special 510(k) pathway for reviewing changes in certain devices.

September 27, 2018 | Daily News

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket.

September 20, 2018 | Daily News

A White House budget official said that the administration is doing “a lot of work right now on medical device stuff that nobody knows about,” and that he hopes to see some of those ideas start coming from CMS in the next six months.

September 18, 2018 | Daily News

A federal Judge on Friday dismissed a suit against Kaiser Permanente that charged the issuer's decision to cover cochlear implants but not hearing aids violated the Affordable Care Act's 1557 non-discrimination provisions, which bars plans from discriminating on the base of race, disability, color, national origin, sex, or transgender status.

September 17, 2018 | Daily News

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

September 12, 2018 | Daily News

The Advanced Medical Technology Association praised a Local Coverage Decision transparency bill that passed the House by voice vote Wednesday (Sept. 13), but the College of American Pathologists is urging the Senate to reinsert a key provision removed by Ways & Means and said the bill's appeals language was weakened prior to the House vote.

September 11, 2018 | Daily News

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place.

September 11, 2018 | Daily News

Device industry and cybersecurity lawyers plan to soon unveil an in-depth report describing a pathway for medical device manufacturers and the wider health care sector to protect against cybersecurity threats.

September 10, 2018 | Daily News

The House on Wednesday (Sept. 12) is set to consider, likely under suspension of the rules, several bills passed by the Ways & Means Committee last week, including legislation to make CMS' Local Coverage Decision process more transparent and to direct HHS to finish updating regulations for the Programs of All-Inclusive Care for the Elderly, according to House Majority Leader Kevin McCarthy's (R-CA) weekly schedule.

September 06, 2018 | Daily News

FDA has launched a new pilot program intended to make the premarket submission process for medical devices more efficient by allowing applicants to use electronic forms to structure their submissions.

September 06, 2018 | Daily News

The House Ways & Means Committee passed a tweaked version of a bill backed by the medical device industry to clarify and make CMS' local coverage determination process more transparent.

September 06, 2018 | Daily News

The House Ways & Means Committee passed a tweaked version of a bill backed by the medical device industry to clarify and make CMS' local coverage determination process more transparent.

September 05, 2018 | Daily News

The House Ways & Means Committee passed four bipartisan health care bills on Wednesday (Sept. 5) -- which would test the use of smart cards to stem fraud, codify a Medicare enrollment fix, require final regulations for the Programs of All-Inclusive Care for the Elderly program and tweak the local coverage determination process -- but some Democrats complained the measures deal with problems on the periphery of Medicare and the health care system.

August 31, 2018 | Daily News

A guidance policy issued by the Department of Justice (DOJ) in November 2017 and then reiterated in a DOJ memo in January has provided industry lawyers a potential new tool to fight FDA enforcement action brought against a company using guidance documents as the basis for enforcement.

August 24, 2018 | Daily News

The American Clinical Laboratory Association (ACLA) and AdvaMedDx are raising concerns with a draft legislative proposal floated by FDA on Aug. 6 that would overhaul federal regulation of diagnostics, including laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs). ACLA asks lawmakers to reject the proposal in its entirety, while AdvaMedDx calls for more discussion on the plan.

August 17, 2018 | Daily News

An industry lawyer said FDA’s recent technical assistance (TA) on a diagnostics regulation reform bill does far more than provide technical comments, and instead proposes an entirely new legislative framework that would shake up the agency’s 42-year-old diagnostic premarket review process.

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