The Food and Drug Administration is classifying hemoglobin A1c test systems as Class II devices that do not require premarket approval, in an order that codifies a classification that took effect May 23, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.
On Aug. 21 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 Aug. 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Aug. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Aug. 11-17, 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 Aug. 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 threatened two seafood importers with import refusal for violations of seafood hazard analysis and critical control point (HACCP) requirements, in two warning letters sent in late July. FDA said New York-based Taiyo Seafood NY ready-to-eat tuna and frozen vacuumed packed tuna Ahi products are adulterated because the company didn’t adequately monitor sanitation at its facility and did not verify that its imported tuna complied with HACCP regulations (here). The agency sent a another letter to Wang Globalnet of Vernon, California, that said the company failed to verify its imported dried anchovy product complied with HACCP rules (here). Wang also failed to renew its registration by the applicable deadline, said FDA. The agency told both companies that it may place affected products on import alert and refuse them entry. FDA also said it may collect fees form each company to cover the cost of any reinspection to verify compliance.
On Aug. 14 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 Aug. 13 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.