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Medical Devices

July 22, 2020 | Daily News

The Senate on Wednesday (July 22) rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Donald Trump to invoke the Defense Production Act to provide states with medical equipment, such as tests, respirators, gowns and gloves.

July 20, 2020 | Daily News

Over the weekend, FDA granted the first emergency use authorization (EUA) for a COVID-19 pooling test to Quest Diagnostics.

July 20, 2020 | Daily News

FDA will temporarily allow commercial manufacturers and labs to distribute and use devices and liquids that are intended to stabilize and transport clinical specimens collected as part of COVID-19 testing, even if they don’t adhere to premarket notification or unique device identification requirements, the agency announced in an enforcement policy guidance published Monday (July 20).

July 16, 2020 | Daily News

Industry experts predict the COVID-19 pandemic will be a catalyst to transition FDA toward conducting electronic-based medical product and facility assessments and facility inspections, and they say the agency needs to provide more clarity about what those inspections and assessments will look like moving forward.

July 15, 2020 | Daily News

The House Energy & Commerce Committee on Wednesday (July 15) passed five bipartisan FDA policy bills that would increase the agency’s authority over imported counterfeit medical devices, stop gaming of certain orphan drug exclusivity provisions, boost use of continuous manufacturing, empower FDA to require labeling updates for generic drugs, and allow the agency to add food ingredients to the list of major allergens.

July 15, 2020 | Daily News

The House Energy & Commerce Committee on Wednesday (July 15) passed to the House floor a bill that would make several policy changes to the Strategic National Stockpile and rethink how medical supplies in the SNS are managed, rotated, distributed and sold off to other government agencies.

July 14, 2020 | Daily News

The House Energy & Commerce Committee on Wednesday (July 15) will mark up a bipartisan bill that would give FDA authority to seize and destroy counterfeit 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.