FDA Guidance: Design Considerations for Devices Intended for Home Use, 11/14
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In November 2014, the CDRH and CBER branches of the FDA published Guidance for Industry and FDA Staff, Design Considerations for Devices Intended for Home Use. This document is intended to assist manufacturers in designing and developing home use devices that comply with applicable safety standards, effectiveness standards, and regulatory requirements.
This guidance contains recommended practices to minimize the unique risks of home use medical devices.
- Section VII, Design Considerations, briefly discusses best practices for home use software design, testing, and upgrades
- Section VII.E, Electrical Issues, details the special considerations that need to be applied for home use of wireless (RF) technologies in medical devices
| Issuing Body | FDA Guidance Documents |
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