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Medical Devices

April 15, 2021 | Daily News

FDA announced Thursday (April 15) that it is withdrawing the list of 83 class II devices and one unclassified device type that the Trump administration had proposed to permanently exempt from 510(k) premarket review, after health care providers and industry both said the proposal posed patient safety and access concerns.

April 15, 2021 | Daily News

FDA this week released long-awaited guidance laying out the agency’s plans for tackling remote facility inspections during the COVID-19 pandemic.

March 26, 2021 | Daily News

Proponents of FDA device regulation hope to see new HHS head Xavier Becerra reinstate FDA’s jurisdiction over laboratory-developed tests after the Trump HHS told the agency it no longer had the authority to regulate the tests.

March 17, 2021 | Daily News

The Biden administration has directed HHS to invest over $12 billion in COVID-19 serial testing, $10 billion of which is allocated for asymptomatic screening testing in K-12 schools and $2.25 billion is set aside for testing underserved populations.

March 16, 2021 | Daily News

FDA is open to authorizing COVID-19 tests that can be used to regularly screen asymptomatic individuals at businesses and schools or at home, even if the tests have not been validated for use in asymptomatic patients, the agency announced Tuesday (March 16), saying it hopes the streamlined pathway to market will expand availability of screening tests and bolster testing programs.

March 11, 2021 | Daily News

President Joe Biden will direct all states, tribes and territories to open up vaccine eligibility to all adults by no later than May 1, the administration announced Thursday (March 11).

March 09, 2021 | Daily News

An at-home COVID-19 antigen test heavily invested in by the federal government as a linchpin for the national pandemic response does not collect data detailing patients’ racial and ethnic background, which some experts say decreases the test less usefulness as a public health tool because it doesn’t show which minority groups are testing positive for the virus at the highest rates.

March 05, 2021 | Daily News

FDA on Friday (March 5) granted emergency use authorization to the first non-prescription molecular COVID-19 test for at-home use.

February 27, 2021 | Daily News

The Biden administration on Friday (Feb. 26) updated and partially reversed Trump administration guidance on insurers’ responsibilities for covering COVID-19 testing, clarifying that non-grandfathered group health plans must fully cover diagnostic testing even if the patient is asymptomatic, except when done for public health surveillance or return-to-work mandates.

February 24, 2021 | Daily News

Stakeholders that offer or manage tax-preferred health savings or flexible spending accounts want Congress -- or the administration -- to tweak IRS rules to clarify that personal protective equipment like masks, shields or hand sanitizer can be considered a qualified medical expense and thus reimbursable for accountholders.

February 24, 2021 | Daily News

While World Trade Organization members remain deadlocked over the question of whether to waive some intellectual property obligations in response to the pandemic, they largely share a common sense that countries must explore how intellectual property flexibilities can be part of a pandemic response framework, according to a Geneva-based trade official familiar with the discussions.

February 23, 2021 | Daily News

As the Biden administration pushes for more over-the-counter and at-home COVID-19 tests, health technology and privacy experts say they’re worried about the lack of privacy regulations in the space.

February 22, 2021 | Daily News

FDA on Monday (Feb. 22) issued two new guidances and updated two existing guidances to guide COVID-19 test, vaccine and therapeutics developers on how to update their products to account for COVID-19 variants.

February 17, 2021 | Daily News

The Biden administration is investing $1.6 billion to increase COVID-19 test and genomic sequencing efforts in the United States, the White House announced Wednesday (Feb. 17).

February 16, 2021 | Daily News

Top FDA device center officials over the weekend acknowledged early agency missteps in regulating COVID-19 serology tests and said moving forward the government should not let serology tests enter the market unless they are authorized by FDA.

February 10, 2021 | Daily News

The House Energy & Commerce Committee wants to give the Centers for Disease Control and Prevention $1.75 billion to conduct, expand and improve genomic sequencing to identify COVID-19 mutations and to expand disease surveillance -- coming as the Biden administration raises concerns the United States lags behind other countries in efforts to track the emerging COVID-19 variants.

February 10, 2021 | Daily News

The Centers for Disease Prevention and Control announced Wednesday (Feb. 10) that double-masking or wearing a single, well-fitted mask is more effective at protecting against COVID-19 than a single disposable mask based on emerging science.

February 09, 2021 | Daily News

The Biden White House has yet to decide whether to restore FDA’s regulation of laboratory-developed tests as it faces pressure from current and former FDA officials to revoke a controversial move by the Trump HHS to ax FDA’s oversight of the products.

February 08, 2021 | Daily News

FDA recently finalized guidance detailing its new, expedited review program for medical device products that improve the safety of existing therapies used for less-serious medical conditions, but developers still have questions about the data requirements. Industry sponsors say it remains unclear what safety data the agency will require when an application is submitted.

February 05, 2021 | Daily News

The federal government has directed six different manufactures to ramp up domestic production of non-prescription, at-home COVID-19 tests under the Defense Production Act, the White House’s COVID-19 Response Team revealed Friday (Feb. 5).