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Medical Devices

September 28, 2020 | Daily News

FDA’s latest clarification of the types of evidence it will use to determine whether companies intend for drugs and devices to be used off-label removes language that industry argued would have unfairly exposed companies to misbranding violations.

September 28, 2020 | Daily News

FDA recently launched its new Digital Health Center of Excellence with the goal of promoting digital health research and partnerships. However, one industry expert says he has doubts about the intent of the program, asserting that it could just be a marketing move to push the agency’s device precertification program.

September 22, 2020 | Daily News

The House again passed two bipartisan bills that aim to give FDA authority to destroy counterfeit medical devices and that direct the agency to establish centers of excellence focused on continuous manufacturing.

September 18, 2020 | Daily News

FDA’s latest report on its software precertification program shows the agency is investing substantial time on the new project, despite not having statutory authority or answering key questions from the industry, device software industry lawyers say.

September 17, 2020 | Daily News

Newly published performance data for COVID-19 laboratory-developed tests show FDA’s desire to be more transparent with test developers and, according to a medical device industry lawyer, could persuade labs seeking to manufacture tests to pursue FDA authorization, even though they’re no longer required to have premarket or emergency authorization from the agency.

September 11, 2020 | Daily News

Top FDA device center officials call for the United States to create a legislative framework for overseeing lab tests and to work with global partners to devise a plan for sharing clinical specimens to ensure diagnostic testing is accurate and reliable in future pandemics.

September 08, 2020 | Daily News

The Laboratory Corporation of American (LabCorp) introduced the first combined diagnostic test for COVID-19, influenza A/B and respiratory syncytial virus (RSV) on Tuesday (Sept. 8).

September 04, 2020 | Daily News

A group of Democratic representatives want three major commercial laboratories to increase pooled testing for COVID-19, specifically in New Jersey, New York and Connecticut, in order to increase testing output while preserving critical supplies.

September 02, 2020 | Daily News

The American Nurses Association wants the Trump administration to invoke the Defense Production Act for N95 masks to help resolve shortages of masks and other personal protective equipment, which it says would help cut down on the reuse and decontamination of masks that are intended only for single-use.

August 31, 2020 | Daily News

CMS on Monday (Aug. 31) proposed a rule to streamline Medicare coverage of breakthrough technologies, more than a year after the White House Office of Management and Budget began reviewing it, although one policy analyst says the proposed definition of “reasonable and necessary” is the rule’s most significant provision.

August 31, 2020 | Daily News

Drug and device industry lawyers are surprised that FDA’s latest inspection guidance fails to expand on whether and how the agency will use remote technologies to conduct facility inspections during the COVID-19 pandemic.

August 27, 2020 | Daily News

FDA on Thursday (Aug. 27) issued its first emergency use authorization (EUA) to a COVID-19 antigen test where the results can be read directly from the testing card, similar to a pregnancy test.

August 26, 2020 | Daily News

A rapid point-of-care breath test for COVID-19 could be commercially available by the fall of 2020, the ECRI Institute asserts in a report published Wednesday (Aug. 26).

August 25, 2020 | Daily News

After the Trump administration moved to cut FDA out of regulation of laboratory-developed diagnostic tests, the leading medical device lobby Advanced Medical Technology Association encouraged its members to continue to validate their tests with the agency before entering the market and vowed to continue working with Congress on legislation to set up a new diagnostic regulatory framework to make tests more readily available to patients.

August 20, 2020 | Daily News

House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) demanded a briefing from HHS Secretary Alexander Azar on why the department decided it will no longer require laboratory developed tests to undergo FDA premarket reviews before coming to market.

August 20, 2020 | Daily News

FDA will no longer require premarket review for laboratory developed tests, including tests developed to diagnose COVID-19, HHS announced Wednesday (Aug. 19).

August 19, 2020 | Daily News

HHS Assistant Secretary Brett Giroir praised a newly approved COVID-19 rapid point-of-care test for its low cost, quick turnaround time and flexible platform that will help give patients a quicker diagnosis, as well as possibly help scale up testing and increase patient access to care.

August 17, 2020 | Daily News

Despite reassurance of "excess" COVID-19 testing supplies from the White House, FDA revealed in its first medical device shortage list posted late Friday (Aug. 14) that there are shortages of COVID-19 testing equipment such as swabs, reagents, storage and transport devices and instrumentation systems due to the public health emergency

August 17, 2020 | Daily News

FDA gave its first emergency authorization for a saliva-based COVID-19 diagnostic test that does not require any special swab or collection device on Saturday (Aug. 15) in the hopes of increasing testing capacity and reducing the current strain on testing equipment.

August 14, 2020 | Daily News

The Congressional Research Service says at-home and over-the-counter COVID-19 diagnostic tests that don’t require a physician’s order and could be quickly read at home, similar to an at-home pregnancy test, would improve testing access, capacity and turnaround time and would facilitate testing in any setting at any frequency, including homes, workplaces and schools.

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