The FDA released an updated list of Emergency Use Authorizations (EUAs) it has issued for medical devices as a result of the COVID-19 pandemic. “These Authorizations contain, among other things, conditions on the emergency use of the authorized products,” the agency said. The EUAs follow from FDA’s determination that, due to the pandemic, “circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices,” it said.
On July 9 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 8 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The FDA's weekly Enforcement Report for July 8 lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On July 7 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 6 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA on July 2 created new Import Alert 66-78 for drugs that appear to be adulterated based on analytic test results. The import alert, which does not yet list any products for detention without physical examination (DWPE), covers “drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution.” Reasons for listing include instances in which testing has revealed harmful impurities; violations of current good manufacturing practices; substandard strength, quality or purity; drugs not recognized in an official compendium; mixing or packing to reduce quality or strength; and drugs that have been entirely substituted. “To secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated,” FDA said.
The FDA issued its weekly Enforcement Report for July 1 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On June 30 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: