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Medical Devices

March 04, 2020 | Daily News

Executives from seven major lab testing companies met with the administration’s Coronavirus Task Force on Wednesday afternoon (March 4) to discuss strategies for quickly disseminating coronavirus diagnostics to as many people as possible.

March 03, 2020 | Daily News

Senate Democrats and Republicans alike said they are concerned the administration is not providing enough affordable and accessible test kits for the coronavirus, after being briefed by top administration officials.

February 28, 2020 | Daily News

FDA announced the first shortage of a human drug as a result of the COVID-19 outbreak and used the opportunity to push legislative proposals it says would help the agency prevent or mitigate medical product shortages.

February 27, 2020 | Daily News

FDA is inviting device makers to voluntarily participate in a pilot that will test a new online application template for premarket clearance, and those participating are expected to have their 510(k) review times cut back and will be allowed to skip a piece of the agency’s preliminary application review process.

February 26, 2020 | Daily News

Senate appropriators on Tuesday (Feb. 25) grilled HHS Secretary Alex Azar on whether the White House’s $2.5 billion supplemental funding request is enough to respond to the coronavirus outbreak and to beef up the U.S. supply of masks, ventilators and other personal protective equipment given other cuts sought by the White House.

February 18, 2020 | Daily News

FDA, the Government of India and U.S Customs and Border Protection stopped nearly 500 shipments of unapproved illicit drugs as part of a bilateral enforcement program known as Operation Broadsword.

February 13, 2020 | Daily News

FDA has identified a recent recall of Medtronic insulin pumps as a class I recall, the most serious category of device recalls reserved for products that can result in serious injury or death.

February 04, 2020 | Daily News

FDA granted emergency use authorization to the first diagnostic test to detect novel coronavirus, the agency announced Tuesday (Feb. 4).

January 31, 2020 | Daily News

The medical device lobby is actively working with the Chinese and U.S. governments and stakeholders to ensure providers and patients have access to medical technologies that can help diagnose and prevent the spread of novel coronavirus, the group told Inside Health Policy on Thursday (Jan. 30), amid reports that China is experiencing shortages of masks, gowns and gloves.

January 30, 2020 | Daily News

The House Energy & Commerce health subcommittee on Wednesday (Jan. 29) discussed several legislative proposals that aim to reform drug manufacturing, update generic drug labels and increase FDA’s authorities over imported medical devices.

January 30, 2020 | Daily News

The over-the-counter drug lobby will broaden its focus to include consumer medical devices, and it plans to work with FDA to establish a definition and standards separate from those used to regulate more traditional medical devices, the Consumer Healthcare Products Association told Inside Health Policy.

January 28, 2020 | Daily News

FDA, the National Institutes of Health and the Office of the Assistant Secretary for Preparedness and Response are researching possibilities for vaccines, diagnostics and therapeutics to respond to the novel coronavirus, of which there are now five known cases in the United States, HHS Secretary Alex Azar said during a press briefing Tuesday (Jan. 28).

January 28, 2020 | Daily News

The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29).

January 27, 2020 | Daily News

Diagnostic test makers who want to pursue emergency use authorization for tests to detect novel coronavirus should contact FDA, the agency said in a press release Monday (Jan. 27) as part of an update on the agency’s response efforts.

January 23, 2020 | Daily News

The House Energy & Commerce oversight subcommittee’s top Republican is pushing legislation that would give FDA authority to seize and destroy counterfeit medical devices, combination products and vaccines coming across U.S. borders.

January 22, 2020 | Daily News

Heading into 2020, third-party medical device servicers will focus on two key issues: extending right-to-repair laws to medical devices, and addressing cybersecurity on older medical devices, industry representatives told Inside Health Policy.

January 07, 2020 | Daily News

FDA will hold a public meeting March 27 to gather input on efforts to reform its data strategy, which the agency laid out in its Technology Modernization Action Plan (T-MAP) in September.

January 02, 2020 | Daily News

The White House budget office is reviewing a final FDA guidance that allows 510(k) applications for low-to-moderate risk devices to be reviewed by a third party for review and only involve FDA for the final decision on the submission.

December 26, 2019 | Daily News

FDA on Friday (Dec. 20) finalized a guidance that details how manufacturers can develop dried plasma products and gain approval of devices used to manufacture dried plasma for application beyond the battlefield.

December 17, 2019 | Daily News

FDA is proposing to no longer publish a list of premarket approval applications and humanitarian device exemption approvals and denials in the Federal Register each quarter, according to a proposed rule published Monday (Dec. 16).

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