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.
The Food and Drug Administration is backtracking on a proposal to reclassify into class III and require premarket approval for cranial electrotherapy devices. The agency is withdrawing a proposed order from April to reclassify the devices, which are used to treat insomnia, depression and anxiety (see 13040420). Instead, it plans to issue a proposed order to reclassify cranial electrotherapy devices into class II, which means they may require premarket notification but not premarket approval.
The Food and Drug Administration on June 11 finalized parts of a new guidance on its database for medical device unique identifiers. The guidance includes information for device labelers (in most instances, the device manufacturer) on how to use the Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. Labelers are required to submit data to GUDID if a device must be labeled with a Unique Device Identifier (UDI), FDA said in its final regulations on the subject. Many parts of FDA’s guidance on GUDID have not been finalized, and have been left blank until they are, said FDA in a concurrent Federal Register notice (here).
On June 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 posted a draft guidance on identification of suspect product in pharmaceutical supply chains and subsequent notifications to FDA, as required by the Drug Supply Chain Security Act. Beginning on Jan. 1, 2015, “trading partners” as defined by the 2013 law must notify FDA when they come across “illegitimate product.” The draft guidance includes scenarios that should raise red flags for supply chain participants, as well as due diligence activities that should be undertaken and the procedure for submitting and terminating notifications when illegitimate product is found. Comments on the draft guidance are due Aug. 11, according to a concurrent Federal Register notice (here).