Officials from the Food and Drug Administration and the Department of Agriculture recently signed a memorandum of understanding on the regulation of imported and domestic catfish. The memo is “intended to facilitate the transfer of primary regulatory oversight over Siluriformes fish and fish products, including commercial catfish, basa, pangasius, and swai/tra, from FDA” to the USDA’s Food Safety and Inspection Service, said FDA (here).
On May 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 on May 8 posted to its website two updated guidance documents intended to assist with compliance with the agency’s new requirements for unique device identifiers (UDIs) on the labels of medical devices and device packages. Under FDA’s September 2013 final rule, the UDI system will be phased in over a seven year period, with marking of class III devices required by September 2014, class II devices by 2016, and class I and all other devices by 2018 (and for reusable devices, on the class I device itself by 2020) (see 13092020). The "GUDID Data Elements Reference Table: (here) summarizes device attribute information that will populate the Global Unique Device Identification Database (GUDID). “UDI Formats by FDA-Accredited Issuing Agency” (here) summarizes the UDI formats for the issuing agencies that FDA has accredited to date.
The Food and Drug Administration is in the process of realigning its Office of Regulatory Affairs (ORA) staff to focus on specific commodities instead of geographic regions, said Howard Sklamberg, FDA deputy commissioner-Global Regulatory Operations and Policy, in a blog post May 9. In a change that appears to echo CBP’s move to the commodity-focused Centers of Excellence of Expertise (CEEs), Sklamberg says FDA’s current geographic model of regional field offices “will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco.”
A French company is recalling cheese it exported to the U.S. after the Food and Drug Administration found contamination by salmonella. Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses, lot number 350. The products were distributed nationwide in supermarkets and gourmet stores between March 10 and May 6, said FDA.Both kinds of cheese come as a 13lb wheel and are usually cut and wrapped, said FDA. FDA said it found the salmonella bacteria in some of Ste Fromagere du Livradois’ products during routine sampling. No illnesses have been reported to date, it said.
On May 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 issued its weekly Enforcement Report for May 7 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 May. 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 May 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: