The U.S. Department of Health and Human Services (HHS) said in a May 7 statement that it has awarded $583 million to nearly 1,400 health centers in all 50 states and the District of Columbia for the expansion of testing for the COVID-19 pandemic. The Health Resources and Services Administration will coordinate the awards, funded in part by the Paycheck Protection Program, and HHS noted that the funds can be used to purchase personal protective equipment to be used during testing. HHS also said it has deployed 50 portable dialysis machines to intensive care units in New York City and Long Island, New York, to provide surge capacity.
The U.S. FDA said in a May 8 statement that it has authorized the first diagnostic test with the option of using saliva for COVID-19 testing. The emergency use authorization for at-home saliva testing is associated with a test developed by the Rutgers Clinical Genomics Laboratory for a lab-developed test that had previously been listed under the EUA for molecular tests. The saliva specimen kit is the LLC SDNA-1000 saliva collection devices by Spectrum Solutions Inc., of Madison, Alabama.
The U.S. Government Accountability Office said the agencies of the U.S. Department of Health and Human Services (HHS) have not used authorities conferred by the 21st Century Cures Act to hire and retain scientists by increasing employee salaries. The May 8 letter, addressed to Sen. Patty Murray (D-Wash.) and Rep. Frank Pallone (D-N.J.), said that officials at both the FDA and the National Institutes of Health (NIH) had indicated that they were encountering difficulty in competing with the private sector to recruit and retain premier scientific talent, although HHS is said to have issued regulations to implement the related authorities under the Cures Act. Both FDA and NIH had indicated that they would begin efforts to make use of the increased salaries, although the FDA had noted that the process in question could take as long as six months to identify recruitment/retention targets.
The Jan. 14 FDA warning letter to Philosys Co. Ltd., of Jeollubuk-do, South Korea, said the manufacturer of self-monitoring blood glucose systems had failed to file a medical device report for an instance of hypoglycemia as a consequence of a malfunction associated with one of the company’s devices. The August 2018 inspection also disclosed a failure to fully evaluate the impact of a change of supplier for test strips for shelf life.
The Feb. 12 FDA warning letter to Bedfont Scientific Ltd., of Kent, U.K., said the October 2019 inspection of the company’s manufacture of carbon monoxide gas analyzers disclosed a failure to demonstrate that units used for customer usability analyses were equal to production units. The agency said the firm’s analysis of quality data was inadequate for corrective and preventive action purposes, and that requirements for test equipment calibration lacked specifications for determining the limits accuracy and precision for flow meters.
The March 26 FDA warning letter to the University of Kentucky said the university’s lab had failed to ensure study data were appropriately retained for a study of an extracorporeal membrane oxygenation system, and that returned goods authorization documents bore incorrect or missing device serial numbers. Lab records are also said to have failed to accurately depict which animals had been euthanized.