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FDA Seeks Importers, Filer Participants for Pilot of new ITACS Accounts
June 22, 2016 |FDA

The Food and Drug Administration will soon begin a pilot to test a new account management function for its Import Trade Auxiliary Communication System (ITACS), it said (here). The use of importer accounts would allow the agency to move to electronic notices of action sent out when the FDA conducts additional review of a shipment, which will allow quicker notification to the filer, importer and consignee, an FDA official recently said (see 1606100012). “Implementation of user login accounts would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication,” the FDA said in its notice. Filers, importers of record and consignees interested in participating in the pilot should email the FDA at itacssupport@fda.hhs.gov (with ITACS Pilot Participation Request in subject line) by July 8. The FDA said it intends to begin the pilot by around July 23, and conclude it in October.

FDA Allows Some Symbols on Medical Device, Biologics Labels
June 20, 2016 |FDA

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.

FDA Releases Guidance on Prior Notice of Imported Food
June 16, 2016 by Brian Feito|FDA

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).