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Medical Devices

November 15, 2018 | Daily News

Scott Whitaker, the president and CEO of Advanced Medical Technology Association (AdvaMed), said he is confident there are enough Senate votes to pass a medical device tax repeal bill before the end of this session of Congress, so long as lawmakers find a legislative vehicle.

November 15, 2018 | Daily News

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

November 08, 2018 | Daily News

FDA and the HHS Office of Inspector General are butting heads over whether the agency is equipped to address postmarket cybersecurity risks to medical devices.

November 08, 2018 | Daily News

Drug industry lawyers are calling for FDA to give more specific feedback during new product reviews to drug applicants, saying the agency’s current process leaves out crucial details and makes the process more frustrating and contentious than necessary.

November 07, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) and the National Organization for Rare Disorders (NORD) are confident that the interests of their constituencies will be well represented despite the shift from a GOP-led to Democrat-led House, plus some changes in the Senate, after the midterm elections.

November 07, 2018 | Daily News

With a Democratic takeover of the House, the powerful Energy & Commerce Committee will experience leadership and priority shifts. A former congressional aide told Inside Health Policy that Democrats may use the opportunity to push the Creating and Restoring Access to Equivalent Samples (CREATES) Act, seek funding options for opioid-related initiatives, focus more on cosmetics legislation and revisit laboratory-developed test (LDT) legislation.

November 06, 2018 | Daily News

FDA on Tuesday (Nov. 6) released a new app that agency chief Scott Gottlieb hopes will enable developers to collect real-world data from patients on new medical products.

November 02, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) is confident that the interests of the medical device industry will be well-represented no matter which party controls the House and the Senate after the midterm elections due to the industry's support from both parties.

November 01, 2018 | Daily News

CMS on Thursday (Nov. 1) finalized changes for the next round of competitive bidding for durable medical equipment, as well as reimbursement rates for suppliers once the current round of competitive bidding ends Dec. 31 until the next round kicks in.

November 01, 2018 | Daily News

HHS has rebranded its cybersecurity center to distinguish it in the department's efforts to defend the health care sector's information technology infrastructure, an HHS spokesperson told Inside Health Policy.

October 25, 2018 | Daily News

Medical device experts voiced their approval of FDA's recent draft guidance that lays out how device manufacturers should address cybersecurity in their premarket submissions.

October 24, 2018 | Daily News

CMS is working on a rule to streamline Medicare coverage of breakthrough medical technologies, according to the agency's most recent regulatory agenda, which was unveiled shortly after CMS Administrator Seema Verma complained about Medicare's inability to quickly cover devices.

October 24, 2018 | Daily News

A key House health care committee suggested Tuesday that Congress bolster efforts by federal regulators to get medical device makers and other industries to ferret out cybersecurity vulnerabilities by offering a liability shield for independent cybersecurity researchers when vulnerabilities are reported, and by helping to distinguish between hacking and good-faith efforts to discover security lags.

October 19, 2018 | Daily News

FDA is planning to move on a range of deregulatory actions in the medical device space, including implementing the timeframes and procedures for how the agency handles internal review of device-related decisions; no longer publishing lists of certain device approvals and denials; and harmonizing domestic and international quality requirements for devices.

October 18, 2018 | Daily News

FDA and the Department of Homeland Security (DHS) have agreed to formally work together to stave off cybersecurity threats facing medical devices.

October 18, 2018 | Daily News

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.

October 12, 2018 | Daily News

A bipartisan group of 32 senators is asking CMS to extend its proposal to apply higher pay rates for durable medical equipment suppliers in rural areas, and Alaska and Hawaii, to also include suppliers in all non-bid areas, and more than 130 House lawmakers also sent a letter to the agency Oct. 12 with a similar request.

October 11, 2018 | Daily News

The national drug and device lobbies this week weighed in on a Utah Supreme Court case that could determine whether FDA approval of a medical device shields the product's manufacturer from strict liability claims over alleged design defects.

October 11, 2018 | Daily News

FDA's move toward developing more product-specific guidances rather than establishing policy through citizen petition responses may cause delays in agency policy development and leave industry left with unanswered questions, especially in the combination products space, one industry representative argued at a recent conference.

October 10, 2018 | Daily News

Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency's emerging precertification program, where precertified software developers would not be subject to premarket review.

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