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Medical Devices

January 18, 2019 | Daily News

FDA released final guidance on Thursday (Jan. 17) that the agency says will encourage the development of antimicrobial susceptibility tests (ASTs) to help determine whether a pathogen will likely respond to, or has developed resistance to, certain antimicrobial drugs.

January 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

January 10, 2019 | Daily News

Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement pre-cert?

January 09, 2019 | Daily News

CMS says in recently released guidance that states do not need to obtain a Medicare denial for certain durable medical equipment coverage before Medicaid, which acts as a secondary payer for those dually eligible for Medicare and Medicaid, can pay for the equipment.

January 08, 2019 | Daily News

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework.

January 07, 2019 | Daily News

Medical device experts say that crafting new regulatory frameworks for laboratory developed tests (LDTs), digital health apps and medical device cybersecurity are among the top FDA-related issues they will be tracking in 2019.

January 04, 2019 | Daily News

Greg Garcia, executive director for cybersecurity of the Healthcare and Public Health Sector Coordinating Council, says the group will be gearing up over the next few weeks to encourage widespread adoption of recently issued cybersecurity guidelines, as it also develops a process for measuring the effectiveness of the voluntary guidance for reducing cyber risks for hospitals, patients and the rest of the medical community.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

January 02, 2019 | Daily News

Nearly two weeks into a government shutdown that has left 41 percent of FDA employees furloughed, an agency expert says the shutdown will disrupt FDA’s long-term planning because it will put off settling the question of how much funding the agency will receive from Congress in 2019.

January 02, 2019 | Daily News

HHS and the healthcare industry issued cybersecurity “best practices” that focus on baseline measures such as protecting emails, limiting system access and developing incident response plans -- based on a pre-testing process intended to assess the effectiveness of the security guidelines.

January 02, 2019 | Daily News

HHS and the healthcare industry issued cybersecurity “best practices” that focus on baseline measures such as protecting emails, limiting system access and developing incident response plans -- based on a pre-testing process intended to assess the effectiveness of the security guidelines.

December 31, 2018 | Daily News

The American Association for Homecare says that durable medical equipment suppliers that want to re-enter former competitively bid markets may be interested in becoming non-participating Medicare suppliers so that they can charge beneficiaries more than the Medicare allowed amount, given that CMS left many of the DME rates relatively low during the gap before the next round of competitive bidding starts.

December 21, 2018 | Daily News

HHS released a contingency staffing plan in anticipation of a possible government shutdown that showed, out of FDA’s 17,397 staff members, 41 percent or 7,053 employees would be furloughed.

December 21, 2018 | Daily News

FDA Commissioner Scott Gottlieb reaffirmed his agency’s pledge to keep a close eye on a female sterility device that has attracted international scrutiny this year for causing serious pain and bleeding in many women implanted with the device.

December 20, 2018 | Daily News

The House on Thursday  passed legislation that delays or repeals several of the taxes in the Affordable Care Act, including the so-called Cadillac tax, the medical device tax and the tax on health insurance plans.

December 20, 2018 | Daily News

In response to a request from the medical device lobby, FDA is extending by 30 days the comment period for its proposed rule that would waive or alter informed consent regulations for minimal risk clinical investigations, according to an agency notice issued Wednesday (Dec. 19).

December 19, 2018 | Daily News

Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher-risk devices.

December 18, 2018 | Daily News

FDA announced two actions Tuesday (Dec. 18) aimed at encouraging industry to take advantage of two accelerated review and development pathways for new devices.

December 18, 2018 | Daily News

A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016.

December 13, 2018 | Daily News

A medical device industry lawyer says a newly unveiled FDA final rule on medical device classification and reclassification improves on the 2014 proposed rule, and it could indicate the agency intends to reclassify more devices as it moves to update its 510(k) process.

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