The U.S. FDA authorized two diagnostics under the emergency use authorization program for testing for the SARS-CoV-2 pathogen, including the authorization for the qSARS-CoV-2 tests by Cellex Inc., of Research Triangle Park, N.C. The Cellex test is designed to detect the presence of two immunoglobulin antibodies in serum, plasma or venipuncture whole blood. The second test is the COV-19 Idx assay by Ipsum Diagnostics LLC, of Atlanta, a nucleic acid detection test that is limited to labs certified to conduct high-complexity tests under the Clinical Laboratory Improvement Amendments of 1988.
The FDA said it will hold a June 9 hearing of the ophthalmic devices advisory committee to review the premarket application for the Visability micro insert by Refocus Group Inc., of Dallas, a bilateral scleral implant for treatment of phakic presbyopia. FDA advised those interested in attending the hearing to check the agency’s website for updates as to “possible modifications” of the meeting.
The Office of Inspector General at the U.S. Department of Health and Human Services said federal guidelines for assessing hospital compliance with terms of participation in Medicare do not explicitly include cybersecurity considerations for networked medical devices. OIG said it is not clear whether the survey protocols in use by accrediting organizations make any evaluations of cybersecurity, either, adding that the agency will evaluate the situation and report its findings sometime in calendar year 2020.
The U.S. Department of Justice said it will distribute a large volume of personal protective equipment, including N95 masks, to state and local authorities in New York and New Jersey that was reclaimed from hoarders. DoJ said it will pay the hoarders fair market value for the items, but that the department will continue to crack down on hoarding of medical supplies needed to manage the COVID-19 pandemic. In a separate statement, DoJ said it is making $850 million available to public health agencies engaged in the effort to address the pandemic. State, local and tribal governments can apply for the grants over the 60 days following the April 1 announcement, and the program may be extended “as necessary.”
Health Canada said in an April 2 statement that it is expediting reviews of products needed to address the COVID-19 pandemic as well as manufacturing site registrations and licensures. The agency said applications for site licensure can be processed within 24 hours of receipt of a completed application, although there is no mention of a waiver of site licensing fees.