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Medical Devices

May 21, 2020 | Daily News

FDA on Thursday (May 21) listed 27 COVID-19 antibody tests that no longer are on the market under FDA’s March 16 policy that allowed tests to be marketed and distributed without FDA authorization as long as the manufacturers notified the agency.

May 21, 2020 | Daily News

CMS is giving Medicare Administrative Contractors broad authority to set payment rates for COVID-19-related tests in their respective jurisdictions until the agency comes up with national Medicare payment rates.

May 21, 2020 | Daily News

FDA is open to authorizing COVID-19 at-home sample collection kits for over-the-counter use, as long as sponsors demonstrate consumers can easily use the tests and interpret results without oversight by a health care professional, an agency official told stakeholders during FDA’s Virtual Town Hall on Wednesday (May 20).

May 18, 2020 | Daily News

FDA, the National Institutes of Health and the Department of Veterans Affairs are working with stakeholders to ensure 3D-printed swabs for COVID-19 testing can be widely manufactured and distributed with proper labeling and packaging, representatives from the three agencies told stakeholders during a virtual town hall on Friday (May 15).

May 15, 2020 | Daily News

HHS and the Department of Defense are working together to restructure the Strategic National Stockpile so that inventory management falls more in line with how DOD handles munitions stockpiles, senior White House officials said.

May 13, 2020 | Daily News

European Union trade officials on Friday (May 15) will discuss EU-U.S. trade relations as the bloc’s trade commissioner, Phil Hogan, looks to refresh the trans-Atlantic relationship and address some irritants between the two on the path to economic recovery.

May 12, 2020 | Daily News

FDA Commissioner Stephen Hahn sent out a memo Monday (May 11) laying out a process to return to in-person surveillance inspections that have been delayed by the COVID-19 pandemic.

May 11, 2020 | Daily News

Senior administration officials on Monday (May 11) lauded FDA for it works authorizing new COVID-19 tests for the market, including the latest Emergency Use Authorization for the first COVID-19 antigen test, which one administration official described as a “major advance."

May 08, 2020 | Daily News

FDA has decided to abandon development of a regulatory pathway that aimed to address cross-labeling issues between medical devices and drugs, and that FDA says would have reduced regulatory burden for device makers seeking approval for device-drug combination products.

May 07, 2020 | Daily News

Sen. Elizabeth Warren (D-MA) urged the Trump administration Thursday (May 7) to increase production of vaccines, therapeutics, diagnostics and medical supplies by creating a federal agency to oversee public-private partnerships for the COVID-19 crisis.

May 07, 2020 | Daily News

National Institutes of Health Director Francis Collins suggested federal researchers should, with appropriate consent, track individuals who have tested positive for COVID-19 antibodies to see whether they develop the disease later down the road.

May 06, 2020 | Daily News

FDA released a temporary guidance Wednesday (May 6) requiring that manufacturers notify the agency of any significant disruption in the medical device supply chain during a public health emergency, in a bid to mitigate devices shortage amid the COVID-19 crisis.

May 06, 2020 | Daily News

Health care technology company Aetion is calling for FDA to implement a cloud-based real-world evidence platform with robust data governance to allow for data queries, archiving, access and aggregation.

May 04, 2020 | Daily News

Following criticism that hundreds of COVID-19 serology tests, some of them allegedly fraudulent, have come to market without any oversight, FDA on Monday gave commercial manufacturers of currently marketed COVID-19 serology tests 10 business days to submit Emergency Use Authorization requests.

April 29, 2020 | Daily News

FDA has set up an “umbrella” pathway for COVID-19 serology tests that allows developers to qualify for Emergency Use Authorization if their tests are independently validated by a designated government agency, such as the National Cancer Institute, and meet certain performance metrics, Timothy Stenzel, head of FDA’s Office of Health Technology, said during a virtual town hall on Wednesday (April 29).

April 29, 2020 | Daily News

FDA recently released a temporary enforcement policy stating it does not intend to pursue regulatory action over distribution of unapproved computerized behavioral therapy and other digital health devices during the COVID-19 pandemic.

April 28, 2020 | Daily News

Key House lawmakers released a concept paper Monday (April 27) outlining FDA and clinical trial reforms they want included in the second iteration of the 21st Century Cures Act, though they say some of the proposals could be wrapped into the next rounds of COVID-19 relief legislation this year.

April 28, 2020 | Daily News

The American Medical Association on Tuesday (April 28) pressed HHS to ensure the results of COVID-19 serology tests, which check blood for disease antibodies, aren’t used to make personal decisions on physical distancing or to attempt to determine immunity to COVID-19.

April 27, 2020 | Daily News

The House oversight committee is concerned that FDA lacks data on the validity of COVID-19 antibody tests, coming as the White House lays plans to rely on serology test results to reopen the economy.

April 21, 2020 | Daily News

U.S. Trade Representative Robert Lighthizer should “immediately and broadly” lift Section 301 tariffs on imports needed to manufacture medical products being used to combat the coronavirus outbreak, Sens. Tom Carper (D-DE) and Pat Toomey (R-PA) said this week.

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