Medical Devices

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.

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.

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.

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.

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.

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.

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

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

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.