Medical Devices

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.

HHS’ new $6.5 million investment in two commercial diagnostic laboratories aims to expand the U.S. testing capacity by 1 million tests per week by utilizing excess supply and expanding the lab workforce, according to Brett Giroir, HHS assistant secretary.

President Donald Trump will sign a “buy American” executive order Thursday afternoon (Aug. 6) that directs FDA to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability, and target dangerous counterfeit drug and medical product imports.

As lawmakers and industry experts criticize lack of federal coordination and slow turnaround times on COVID-19 diagnostic tests, HHS Assistant Secretary for Health Brett Giroir asserted that reports of widespread delays in receiving test results are largely inaccurate and that there are no significant problems with securing testing supplies.

FDA announced Wednesday (July 29) that it will decrease application costs for its prescription drug user fee program in fiscal 2021, but it will increase overall program fees by about $11,000 over fiscal 2020 levels, for a total of about $336,000.

The brand drug lobby and patient groups say the next iteration of prescription drug user fee legislation should expand use of decentralized clinical trials and digital health technologies that can collect data remotely.

Senate Judiciary Committee Chair Lindsey Graham (R-SC) and Senate health committee Chair Lamar Alexander (R-TN) introduced bills Monday (July 27) that aim to ramp up domestic procurement and manufacturing of medical products, and provide tax credits to qualifying personal protective equipment manufacturers.

The Senate on Wednesday (July 22) rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Donald Trump to invoke the Defense Production Act to provide states with medical equipment, such as tests, respirators, gowns and gloves.

FDA will temporarily allow commercial manufacturers and labs to distribute and use devices and liquids that are intended to stabilize and transport clinical specimens collected as part of COVID-19 testing, even if they don’t adhere to premarket notification or unique device identification requirements, the agency announced in an enforcement policy guidance published Monday (July 20).