On June 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 17 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 June 15 issued a final rule (here) allowing use of symbols on labeling for medical devices and biological products. The symbol must have been established as part of a standard developed by a nationally or internationally recognized standards development organization and used according to that standard. Alternatively, symbols not recognized or not used in accordance with the standard may still be used if the meaning is likely to be clearly understood by the public. Either way, the symbol must be explained in a symbols glossary that accompanies the device, the agency said. FDA is also proposing to allow the statement “Rx only” on the labeling of prescription devices. The new regulations take effect Sept. 13.
On June 16 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 15 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On June 15 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 an updated guidance on prior notice for imported foods (here). The agency had not updated the questions and answers document since 2004, and in the meantime formally adopted the interim final rule that established prior notice requirements and issued another final rule requiring importers notify the FDA if an article has previously been refused entry. The agency requested public comments on a draft version of the guidance in 2014 (see 14032819), but made "no substantive changes" for the final guidance, the FDA said in a Federal Register notice (here).
On June 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 10 and 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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: