The CDRH Home Health Care Committee was formed in June 2001 in response to the Center Strategic Plan's goal to look at medical devices through the Total Product Life Cycle.

CDRH currently defines a home medical device as a device intended for use in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a health care professional in order to be used safely and effectively.

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Medical Device Home Use Initiative

• Medical Device Home Use Initiative - White Paper (PDF - 56KB)
• Home Use Devices