During the week of Sept. 9-15, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Sept. 10 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for September. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Sept 9 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 reclassifying dengue virus nucleic acid amplification test reagents as Class II devices that do not require premarket approval, in a final order that codifies a reclassification that took effect May 24, 2012. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying the devices in response to a request from the Centers for Disease Control. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics and labeling. The dengue virus test reagents will not be exempt from premarket notification requirements.
The Food and Drug Administration announced a new small entity compliance guide to help small businesses with new unique device identifier requirements for medical devices that begin taking effect Sept. 24 (see 13092020). The guide includes sections on what devices are required to bear UDIs, label requirements, data submission requirements, and compliance dates. Comments on the guide may be submitted at any time, said FDA.
During the week of Sept. 1-6, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Sept. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 4 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 Sept. 3 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.