Cette traduction est en cours de préparation. En attendant, nous affichons temporairement la version originale en anglais.
Entreprise · 08/11/20051 min de lecture
Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is proposing to amend the classification regulations of tinnitus masker devices in order to specify a special control for the device. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →