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
- Docket Number:
- FDA-2013-D-1295
- Issued by:
-
Guidance Issuing OfficeCenter 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.
Submit Comments
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
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-1295.