The Food and Drug Administration will refuse entry of Cavi-Lipo devices from South Korean device manufacturer SkinRex because it is being marketed for unapproved uses, said the Food and Drug Administration in a warning letter dated Dec. 12. Although electric therapeutic massagers are exempt from premarket notification, SkinRex is marketing its Cavi-Lipo device for use in the treatment of cellulite, and compares the treatment to liposuction in its marketing materials. As such, the device needs premarket approval from FDA, which SkinRex did not obtain, said the agency. FDA said it is “taking steps to refuse entry of these devices in the United States” through detention without physical examination.
The Food and Drug Administration issued its weekly Enforcement Report for Jan. 1 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Jan. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 27 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 will allow more time for public comments on its proposal to recognize partially hydrogenated oils as unsafe. The agency’s Nov. 8 notice said FDA intends to reclassify partially hydrogenated oils as food additives, because of they’re associated with an increased risk of heart attacks (see 13110827). Although comments were originally due Jan. 7, FDA says it will accept comments until March 8 because of multiple requests for an extension.
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 26 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Dec. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 23-24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: