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Medical Devices

July 10, 2020 | Daily News

A Massachusetts-based nurses union is pushing back on the Trump administration’s calls for health care workers on the frontlines of COVID-19 response to reuse personal protective equipment, including N95 respirators.

July 09, 2020 | Daily News

Regulatory experts say drug and medical device makers want more clarification about FDA’s view on decentralized clinical trials and how new flexible trial policies, including options for remote visits and monitoring, will be applied beyond the COVID-19 pandemic.

July 07, 2020 | Daily News

The Democratic leaders of key congressional health committees say recent Trump administration guidance that says insurers are not required to cover COVID-19 testing for surveillance or return to work screenings clashes with congressional intent.

July 02, 2020 | Daily News

FDA this year will once again attempt to clarify the types of evidence that should be considered when determining a product’s intended use.

July 01, 2020 | Daily News

HHS expects that an additional 5 million COVID-19 point-of-care tests will come onto the market this month, which should bring the total number of available point-of-care tests to 10 million, Assistant Secretary for Health Brett Giroir told reporters on Wednesday (July 1).

June 30, 2020 | Daily News

Senators on both side of the aisle raised concern with White House Coronavirus Task Force members that employees and students who must take COVID-19 tests to return to work or school could get stuck with large bills due to the Trump administration’s recent guidance.

June 24, 2020 | Daily News

FDA chief Stephen Hahn said the COVID-19 pandemic has shed light on the need for increased use of real-world evidence to help regulators make decisions in real time, and he asked Congress to provide more support for advancing generation of RWE.

June 23, 2020 | Daily News

Members of the White House Coronavirus Task Force told lawmakers that no one in the Trump administration directed them to scale back coronavirus testing, even though the president said repeatedly that he’d like the United States to slow down testing.

June 23, 2020 | Daily News

Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended.

June 22, 2020 | Daily News

President Donald Trump and White House officials issued contradictory messages about whether the administration is slowing tests for COVID-19, and Democrats accused the administration of withholding testing funds.

June 18, 2020 | Daily News

Stakeholders are concerned that China’s list of COVID-19 tests that are authorized for export is preventing myriad coronavirus diagnostic and serology tests from being sent to the United States, even though those tests are authorized for distribution in America.

June 16, 2020 | Daily News

FDA on Monday (June 15) authorized the first game-based medical device for treatment of attention deficit hyperactivity disorder in adolescents.

June 16, 2020 | Daily News

The Information Technology & Innovation Foundation, a non-profit think tank that focuses on public policy and innovation, is concerned the Trump administration’s latest push to “Buy American” could have unintended consequences on the medical product supply chain, despite the administration’s assertions that it could help ease American reliance on foreign drug production.

June 10, 2020 | Daily News

Lawmakers on both sides of the aisle on Tuesday (June 9) asked administration officials how many diagnostic tests and how much protective gear the administration has stockpiled for the next wave of the coronavirus.

June 09, 2020 | Daily News

House lawmakers and public health experts on Tuesday (June 9) called for FDA to quickly remove unauthorized COVID-19 serology tests from the market pending agency review to prevent so-called junk tests from being marketed and sold to doctors and consumers.

June 08, 2020 | Daily News

A nursing trade association group called for a complete end to reusing N95 and KN95 masks after FDA rolled back its emergency use authorizations (EUAs) for reuse of certain respirators due to safety concerns over the effectiveness of decontaminating them.

June 02, 2020 | Daily News

Third-party medical device servicers want Congress, FDA and CMS to ensure that, post-COVID-19, servicers will still be able to obtain critical device servicing materials, including equipment manuals and training, access to which has increased during the pandemic thanks to collaboration between servicers and device makers.

June 01, 2020 | Daily News

FDA chief Stephen Hahn has asked agency officials to look into whether some of the more flexible and novel approaches FDA has taken to respond to COVID-19, including allowing remote clinical trial visits, using real-world evidence to make certain regulatory decisions and streamlining lab test approvals, could be applied more broadly and on a more permanent basis.

May 29, 2020 | Daily News

FDA on Friday (May 29) published a voluntary Emergency Use Authorization template for COVID-19 at-home sample collection kits.

May 29, 2020 | Daily News

FDA on Friday (May 29) took several steps to improve and ramp up use of the agency’s Orange Book in a bid to provide more timely and accurate information about generic drugs and spur generic drug competition.

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