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GUIDANCE DOCUMENT

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Final Guidance for Industry and FDA Staff Final Guidance for Industry and FDA Staff February 2009

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-1295
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document identifies applicable legal requirements under the Food, Drug, and Cosmetic Act (the Act) for hearing aids and for personal sound amplification products (PSAPs). Hearing aids and PSAPs both affect our ability to hear sound, but the products have different intended uses, and are therefore subject to different regulatory controls.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1295.

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