FDA Seeks Comments on Foreign Letters of Approval for Medical Devices

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.

(Federal Register 03/11/19)