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GUIDANCE DOCUMENT

Design Considerations for Devices Intended for Home Use Guidance for Industry and Food and Drug Administration Staff November 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-1161
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.

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Submit Comments Online

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-2012-D-1161.

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