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Medical Devices

February 01, 2021 | Daily News

FDA is considering updating its COVID-19 emergency use authorization test templates to ask antigen test developers how they plan to monitor for variant strains of the virus and to ensure that authorized tests can properly diagnose the new strains.

January 28, 2021 | Daily News

When Trump’s CMS finalized its policy to immediately cover breakthrough medical devices following FDA approvals, the agency decided against expanding the new rule to drugs.

January 26, 2021 | Daily News

Nurses want FDA to completely end the reuse of N95 masks and say the agency’s latest action falls short, after FDA on Friday (Jan. 22) reissued an emergency use authorization that said the respirators should only be decontaminated and reused a maximum of four times.

January 22, 2021 | Daily News

One of President Joe Biden’s executive orders out Thursday steps into the still smoldering issue over coverage of non-diagnostic COVID-19 testing, demanding that HHS clarify insurers’ responsibilities.

January 21, 2021 | Daily News

President Joe Biden unveiled a national COVID-19 testing strategy that aims to dramatically increase the number of Americans tested as part of a new seven-pronged massive public health effort to mitigate the spread of COVID-19.

January 21, 2021 | Daily News

President Joe Biden on Thursday (Jan. 21) signed an executive order directing HHS and other agencies involved in COVID-19 response to take immediate action using all available authorities, including using the Defense Production Act, to fill vaccine, testing and personal protective equipment supply gaps and to take steps to address the pricing of pandemic response supplies.

January 14, 2021 | Daily News

President-elect Joe Biden late Thursday (Jan. 14) unveiled a $1.9 trillion COVID-19 relief package that would pump $20 billion into a national vaccination program that results in 100 million vaccinations by the end of his first 100 days.

January 12, 2021 | Daily News

In another 11th-hour move, the Trump CMS finalized Tuesday (Jan. 12) a rule, long-sought by the medical device industry, that provides instant Medicare coverage of FDA-designated breakthrough technology.

January 11, 2021 | Daily News

FDA is working to identify new mutant strains of COVID-19 and analyze how they respond to current diagnostic tests, agency chief Stephen Hahn told reporters on a Friday (Jan. 8) press briefing, just a few hours before FDA alerted health care providers it has identified three emergency authorized tests that could produce false negative results with a potential mutated variant of SARS-CoV-2.

January 07, 2021 | Daily News

HHS Assistant Secretary Brett Giroir said the department is “very confident” an improved congressional COVID-19 testing system will be in place in time for President-Elect Joe Biden’s inauguration, coming after FDA warned earlier this week that the test currently used by members of Congress could be faulty.

January 05, 2021 | Daily News

Device manufacturers hope FDA will draft guidance laying out strict requirements for device servicers in 2021 after deregulation of third-party servicers was discussed in 2020 due to the COVID-19 public health emergency.

January 05, 2021 | Daily News

Industry lawyers say it is unclear how FDA will handle on-site facility inspections as the COVID-19 health emergency spills into 2021 and sponsors of COVID-19 vaccines and therapeutics that received emergency use authorization move toward full approvals.

January 04, 2021 | Daily News

FDA forecasts plans in its latest unified agenda to propose seven new rules, none of which have been included in previous agendas.

January 04, 2021 | Daily News

The drug and device industries are pushing back against FDA’s plans to finalize a rule this month that will amend the definition of “intended use,” alleging the rule would violate the First and Fifth Amendments.

December 29, 2020 | Daily News

FDA wants developers of at-home and over-the-counter COVID-19 tests to ensure their testing platforms are set up to report users’ results to public health officials, but one cybersecurity consultant warns that allowing software to share user information raises the potential for cybersecurity and data integrity issues.

December 18, 2020 | Daily News

FDA is proposing to revoke its regulations covering human tissue products intended for transplantation that were recovered before May 25, 2005, the agency says in a Friday (Dec. 18) Federal Register notice.

December 18, 2020 | Daily News

The Trump administration on Thursday argued that an initiative aimed at facilitating trade in medical goods put forward by a group of members, including the European Union, was unnecessary because its advocates have not proven there is a problem to be solved.

December 15, 2020 | Daily News

FDA on Tuesday (Dec. 15) authorized for emergency use the first fully at-home over-the-counter COVID-19 diagnostic test.

December 14, 2020 | Daily News

The Congressional Research Service says HHS’ decision to remove laboratory-developed tests from FDA oversight yet still require the agency to review voluntarily submitted emergency use authorization requests raises several regulatory and coverage issues.

December 09, 2020 | Daily News

LabCorp’s Pixel COVID-19 Test Home Collection Kit became the first direct-to-consumer non-prescription COVID-19 diagnostic test to receive emergency use authorization from FDA, the agency announced Wednesday evening (Dec. 9).

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