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www.fdanews.com/articles/114127-us-fda-seeks-input-on-medical-exports

US FDA Seeks Input on Medical Exports

January 28, 2009
The FDA is seeking comment on reporting requirements for companies planning to export medical products to countries that need a special certificate from the agency, according to a notice published in the Federal Register last month. A section of the FDA Export Reform and Enhancement Act of 1996 authorized the FDA to issue export certificates for legally marketed devices, pharmaceuticals and biologics, as well as those products that are not officially sold in the U.S. but are acceptable to the importing country.
International Medical Device Regulatory Monitor