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Zdrowie i gospodarka · 29.03.1999

Medical Devices; Exemptions From Premarket Notification; Class II Devices

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for audiometers with certain limitations. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

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