Medical Device Home Use Initiative

• Date: May 03, 2010
• Source: www.fda.gov

Assuring the safety and safe use of medical devices in the home is becoming an increasingly important public health issue. The U.S. Food and Drug Administration (FDA) recognizes the importance of safe, high-quality home healthcare and medical devices that are capable of meeting patients’ needs in the home.

This document announces the launch of FDA’s Medical Device Home Use Initiative. Through this initiative, FDA will take the following actions to support the safety and safe use of medical devices in the home:

1. Establish guidelines for manufacturers of home use devices;
2. Develop a home use device labeling repository;
3. Partner with home health accrediting bodies to support safe use;
4. Enhance postmarket oversight; and
5. Increase public awareness and education.

These steps will help address the challenges associated with the use of medical devices in the home and provide greater protections for patients receiving home healthcare.

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