Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

August 17, 2022

Last updated

October 17, 2022

Description

This document provides guidance for industry and FDA staff on regulatory requirements for hearing aid devices and personal sound amplification products.

Organization

Country / Region

United States

License

Other (Public Domain)

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