The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for July . 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 July 8 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 amending its regulations to require monthly reports by tobacco importers and domestic manufacturers. The monthly reports are currently required by the U.S. Department of Agriculture under the Fair and Equitable Tobacco Reform Act’s Tobacco Transition Payment Program, but FDA is taking over because the USDA reporting program is ending in September and FDA still needs the information in order to calculate tobacco user fees. The information required in the monthly reports to FDA will be “essentially the same” as the elements currently required by USDA, as will the method by which FDA calculates user fees, it said. The first monthly reports will be due to FDA by Oct. 20.
On July 7 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 30 - July 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 July 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 announced a new agreement aimed at improving regulatory cooperation and harmonization with the regional public health organization for the Americas. The cooperative agreement follows an earlier four-year agreement between FDA and the Pan American Health Organization that was signed in September 2010. Through the new agreement, FDA will provide $2 million to the Pan American Health Organization for use toward improving regulatory harmonization and building capacity. The agreement is set to last five years.
The Food and Drug Administration is classifying transcranial magnetic stimulators for headache treatment as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect Dec.13, 2013. FDA is classifying the devices in response to a request from eNeura Therapeutics related to the Neuralieve Cerena system. As Class II devices, transcranial magnetic stimulators will not need FDA pro-approval, but they will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.
On July 2 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 July 2 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.