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Zdrowie i gospodarka · 07/11/2013

FDA Releases Draft Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

The Food and Drug Administration (FDA) has made available a draft guidance document clarifying the regulatory distinctions between hearing aids and personal sound amplification products (PSAPs), and the applicable controls for each, which is not yet final or in effect.

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