The U.S. FDA posted an update to the March 20, 2020, immediately-in-effect policy for noninvasive remote monitoring devices for the COVID-19 pandemic, which adds several product codes to the initial list of the scope of the policy. The agency will exercise enforcement discretion for changes to existing cleared devices that are applied to indications for use, claims, functionality, and hardware or software. Such modifications can be undertaken in order to make an inpatient-only remote monitoring device available for home use, and includes four product codes for cardiac monitors, including cardiotachometers and rate alarms.
The U.S. Department of Health and Human Services said in a June 4 policy document that all diagnostic labs should report testing results for all completed tests for the SARS-CoV-2 virus within 24 hours of the results being known. These results should be reported to the state or local authority of jurisdiction via a Health Level 7 or CDC reporting mechanism, or via other platforms, such as that set up by the Association of Public Health Laboratories. Reports should provide information on the test, device identifier, patient demographic data (including zip code of residence), and patient name and address, although names and addresses should not be sent to CDC.
The FDA has posted a Powerpoint file for testing supply substitution strategies for diagnostic COVID-19 testing, including information specific to polymerase chain reaction testing components and specimen collection kits, as well as extraction systems and supplies. The file also offers information on substitute PCR systems and controls, but the agency emphasized that the availability of the information is not intended to alter or overwrite an existing emergency use authorization.
The FDA updated the list of serological tests that have been evaluated by the National Cancer Institute, providing sensitivity and specificity information for five tests. The NCI validation checked each of the tests for three antibody isotypes as well as a pan-isotype evaluation, although the FDA noted that the samples used in these evaluations were not the results of random sampling.