The information must be satisfactorily provided before the products will be allowed to enter the country. Importers should order products manufactured in accordance with the applicable U.S. standards and with appropriate certification labels affixed. Such orders should be readily filled since there are many foreign manufacturers producing devices for export which comply with the U.S. standards. Laser Products - This standard pertains to all laser products, as well as products containing lasers. Only certified facilities that are in compliance with uniform Federal standards for safe, high quality mammography services may lawfully operate.
Certification establishes that the facility meets the mammography quality standards.
These requirements apply to all facilities producing, processing, or initially interpreting mammograms, whether for screening or diagnostic purposes, except for facilities of the Department of Veterans Affairs. For additional information, refer to the regulations or contact the nearest FDA office .