FDA released on Nov. 19 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 Nov. 17 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 16 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 13 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has created a new import alert for ready-to-eat human foods that don’t meet the agency’s preventive controls regulation requirements. New Import Alert 99-43 published Nov. 13 provides for detention without physical examination of “Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” its title says.
On Nov. 10 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has issued its weekly Enforcement Report for Nov. 11, listing 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 Nov. 6 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 5 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 4 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: