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.
Export Filing and PGAs
to
Refine Category Search
Clear Terms
Search Primer
Term list: Separate terms with spaces, not commas or semicolons.
Multi-word term: Place inside quotes to ensure an exact match (e.g. "foreign direct product rule").
Acronyms: Use all capital letters to ensure the search is not looking for that letter sequence instead. (e.g., BIS).
Required term: If a term must be included in any resulting articles, prefix it with a plus sign (e.g., BIS +Huawei).
Excluded term: If a term should be excluded from any articles being found, prefix it with a minus sign (e.g., China -tariff).
Simplest form: Use the simplest form of a term (e.g. "russian export control" instead of "russian export controls" or "entity list" instead of "entity listing").