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Zdrowie i gospodarka · 7.11.2002

Medical Devices; Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System; Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System; Guidance for Industry and FDA." This document describes a means by which transcutaneous air conduction hearing aid systems (TACHAS) may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying TACHAS into class II (special controls).

Source: Federal Register — Food and Drug AdministrationOpen original release →