Home Use Initiative
December 12, 2012
Today FDA is updating stakeholders (i.e., family care givers, home care recipients, the home health industry, and health care professionals) on progress made under the home use initiative
. Since launching the home use initiative in 2010, the FDA has taken additional steps to assure the safety, quality, and usability of devices labeled for home use. Specific efforts include:
1) Developing a draft guidance document recommending actions that manufacturers should take to receive FDA approval or clearance of devices intended to be used in the home.
The draft guidance is intended to improve design and quality of home use devices to eliminate or reduce errors that occur during their use. It provides recommendations that take into account the device user, the use environment, the device itself and its labeling. FDA is interested in your feedback. You may submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register notice announcing its availability.
2) Developing a home use device labeling repository for medical devices that have been approved or cleared for home use.
Home care recipients, consumers, and caregivers need ready access to information on medical devices used in their home. Health care professionals also need ready access to labeling that may not always accompany a medical device. In the interest of ensuring that consumers and health care professionals can easily locate labeling for devices, especially those intended for home use, the FDA initiated a labeling repository pilot. Prior to its completion in 2011, this pilot program provided manufacturers of devices labeled for home use with the opportunity to voluntarily submit their labeling electronically to FDA and then work with the agency to identify the most streamlined approach to foster the development of a labeling repository.
The FDA will continue to work with interested stakeholders to explore the feasibility of making labeling available on the Internet.
3) Increasing public awareness
FDA will continue to strengthen collaborations with other federal agencies, as well as with external organizations to provide home care recipients, consumers, caregivers, and health care professionals with information about potential safety concerns surrounding medical device use in the home. For example, the FDA has partnered with Kwikpoint, under a Cooperative Research and Development Agreement, to enable the company and the FDA to work collaboratively when designing visual communications aids for various medical devices, such as patient lifts and sharps containers.
Additional information can be found at:
Please contact our Division of Small Manufacturers, International and Consumer Assistance at email@example.com
or 1-800-638-2041 if you have any questions or concerns. Thank you for your support of FDA and its mission.