Delays for exporters seeking approval of labeling by the Food Safety and Inspection Service are now up to 24 to 25 business days, FSIS said in its March 8 constituent update newsletter. To minimize the delays, exporters should “clearly indicate the specific reasons(s) for temporary approval,” and “combine multiple labels into one temporary approval application if appropriate,” FSIS said. Label approval is only required for a few types of labels, but that includes products for export with labeling deviations from domestic products. Delays for labeling approvals have increased slightly since late February.
The Food and Drug Administration seeks comments on the burden on exporters of its requirement to obtain foreign letters of approval for the export of unapproved medical devices, it said. FDA requires that, for devices it has not approved that are to be exported, the exporter provide either a letter from the government of the importing country that the device is approved there, or a certification from a company official in the U.S. that the device doesn't violate the foreign country's laws. The agency is set to request an extension from the Office of Management and Budget for the existing information collection requirement. Comments on the requirements and FDA’s estimate of their burden on importers are due May 10.