The Food and Drug Administration is formally reclassifying pancreatic drainage stent and delivery systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect Dec. 18. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Xlumena, Inc. related to the AXIOS Stent and Delivery System. 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. pancreatic drainage systems will not be exempt from premarket notification requirements.
On May 27 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 May 19-25, 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 will hold a public meeting June 26 in Washington on its proposal to revise nutrition facts labels on food. Two FDA proposed rules issued in March would revise the information required on nutrition facts labels, set additional recordkeeping requirements, increase serving sizes and require new information for packages that contain more than one serving but could be consumed in one sitting (see 14022713). FDA’s meeting will also be webcast. Registration is available (here).
On May 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 22 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 allowing more time for comments on its proposed revisions to nutrition facts labeling for food (here) and (here). FDA’s proposed rules would revise the information required on nutrition facts labels and require that manufacturers keep records on added sugar, the amount of dietary fiber, and certain vitamin contents (see 14022713). FDA is also proposing to increase recommended serving sizes to bring them into line with current eating habits, and would require an additional column of nutrition information for packages that contain more than one serving but could be consumed in one sitting. Comments are now due Aug. 1.
The Cheese Importers Association of America (CIAA) urged the Food and Drug Administration not to paint with too broad a brush as it devises its list of high-risk foods subject to increased recordkeeping requirements. In comments dated May 21 submitted in response to FDA’s proposed criteria for designating high risk foods, the CIAA said the agency shouldn’t use overly broad product categories that would lump safe products in with foods that actually are high-risk.
On May 21 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 21 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.