During the week of June 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 and/or surveillance of:
The Food and Drug Administration will allow more time for comments on the implementation of new reporting requirements under the Food Safety Modernization Act. Under FSMA, human and animal food facilities that are required to register with FDA must submit consumer-oriented information for use in the agency’s Reportable Food Registry. FDA in March asked for comments on the information that should be provided and how that information should be passed onto consumers (see 14032516). It is now extending the period for submitting comments until Aug. 18.
On June 13 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 is classifying nonabsorbable expandable hemostatic sponges for temporary internal use as Class II devices that do not require premarket approval, in an order that codifies a classification that took effect April 3. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying them in response to a request from RevMedx related to its XSTAT device. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing, biocompatibility and labeling. They will not be exempt from premarket notification requirements.
On June 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 11 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 June 11 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On June 10 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 June 2-8, 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:
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for June. 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.