On April 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 10-15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for April 15 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.
The Food and Drug Administration issued its weekly Enforcement Report for April 8 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 April 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration on April 3 issued a new emergency use authorization (EUA) for importing non-NIOSH-approved N95 respirators from China, it said in a letter to importers, manufacturers and healthcare personnel. The EUA “makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic,” FDA said in a new frequently asked question added to its website. Chinese-made KN95 respirators had previously been ineligible for an EUA issued in late March for other non-NIOSH approved respirators “because of concerns about fraudulent products listed as KN95s,” FDA said.
The Food and Drug Administration recently issued two new documents detailing its enforcement policies for infusion pumps and electronic thermometers during the COVID-19 pandemic. The agency’s April 4 enforcement policy for electronic thermometers allows distribution of devices that are not 510(k) cleared under certain conditions. The enforcement policy for infusion pumps, issued April 5, allows “manufacturers that make device modifications to address manufacturing limitations or supply shortages related to the public health emergency,” FDA said.
On April 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: