Zdrowie i gospodarka · 27.11.1995

Export Requirements for Medical Devices

The Food and Drug Administration (FDA) is proposing to amend its regulations for investigational devices to streamline requirements for persons seeking to export unapproved medical devices. The proposed rule would establish that FDA approval of an investigational device exemption application (IDE) constitutes an agency determination that the export of the unapproved device is not contrary to the public health or safety. The proposed rule would also consider a country as approving importation of an unapproved device if the country has notified FDA that it approves of the importation of unapproved devices with an approved IDE into their countries. Thus, for devices with an FDA-approved IDE, the proposal would eliminate the need for FDA to make independent determinations either that exportation is not contrary to the public health or safety or that an importing country approves the importation of a specific device. The proposed rule is intended to codify and to simplify export requirements for certain unapproved devices pursuant to the President's and Vice-President's ``National Performance Review,'' as reflected in the April 1995 report titled, ``Reinventing Drug & Medical Device Reg