The U.S. FDA has posted a guidance dealing with supplemental filings for PMAs and humanitarian device exemptions during the COVID-19 public health emergency, stating that the agency would not object to limited modifications to device design and manufacturing that would ordinarily trigger a requirement for a supplemental regulatory filing. The terms of the policy are restricted to “limited modifications” that could affect the safety and/or effectiveness of a device, including a change of design and manufacturing to compensate for component unavailability. Any manufacturing changes undertaken to provide sufficient distance for social distancing between employees are also within the scope of the policy, as are changes to the manufacturing facility or establishment undertaken to address supply chain disruptions. Manufacturers are still liable for documenting conformance with the related aspects of the Quality Systems Regulations, such as functional testing and software/firmware validation.
The U.S. Government Accountability Office (GAO) said in a May 20 report that the performance characteristics of some tests for the SARS-CoV-2 virus are the source of concerns about test accuracy, specifically the fates of false positives and negatives, and the associated uncertainty has complicated both patient treatment and public health decision making. The agency also noted that it may be difficult to balance the need for high-volume testing, such as is abetted by lab tests, and the need for quick turn-around of results, as is provided by point-of-care tests. Among the policy questions surrounding testing during a pandemic are those revolving around the ability of the FDA and the CDC to facilitate development and use of tests during a pandemic, and the type of information needed by policymakers to decide the number and distribution of tests “to most effectively respond” to pandemics and other outbreaks. GAO said it will provide additional details on these and other questions in subsequent reports.
The U.K. National Institute for Health and Care Excellence (NICE) said the available evidence for the use of cytokine-absorption devices includes a non-randomized, comparative single-arm observational study and a series of case reports of 56 patients with COVID-19 and respiratory failures. The associated reduction of cytokines may improve lung function, but NICE said these data have not been subjected to peer review. None of the case reports were for patients treated in the U.K., and NICE said the sponsor, Cytosorbents Corp., of Monmouth, N.J., has proposed a charge of adsorption cartridges of £450 to £1,785, while cost of the extracorporeal circuits are priced at £10,000 to £60,000. Some of these machines are already placed in U.K. trusts, but NICE said the resource impact would be additive to the cost of additional care inasmuch as the treatment would not replace any existing standard of care.