The U.S. Food and Drug Administration announced Tuesday the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Monday night, the FDA issued a guidance for remote ophthalmic assessment and monitoring devices. These devices include visual acuity charts, visual field devices, general use ophthalmic cameras, and tonometers. The guidance will help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.
- Monday night, the FDA also issued a guidance for extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to help expand the availability of devices used in ECMO therapy.
- The FDA released a guidance document, Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency, to provide producers of shell eggs that normally would be sent to facilities for further processing the flexibility to sell their eggs for distribution to retail locations, such as supermarkets, when certain conditions are present. This flexibility will help egg producers meet increased demand for shell eggs by consumers at retail locations. To learn more, please see the Constituent Update.
- Tuesday, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg. for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, 30 emergency use authorizations have been issued for diagnostic tests.
- The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.