Medical Devices

FDA Activities: Home Use Devices

Through collaborations with industry, the standards community, patients, health care providers and other stakeholders, the FDA continues to support the safe use of medical devices in the home setting. The FDA continues to:

  • Evaluate information from multiple sources, including medical device adverse event reports to identify safety issues with home use devices.
  • Collaborate with clinicians involved in home care to understand their experiences and needs with medical device labeling.
  • Communicate with patient groups and home care professional societies to increase FDA’s knowledge and understanding of their unique and changing needs to facilitate safe device use.
  • Participate in standards development for devices used in the home.
  • Organize and participate in public meetings to discuss issues associated with patient labeling for medical devices.
  • Develop guidance with recommendations for healthcare provider and patient labeling.

Page Last Updated: 01/24/2018
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