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.
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: