- What is a Home Use Device?
- Why is FDA's Center for Devices and Radiological Health (CDRH) interested?
- What can CDRH do?
- What information does this website provide?
- Links to Informational Videos
A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.
- A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
- A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.
Changes in health care have moved care from the hospital environment to the home environment. In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.
As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.
CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. CDRH has been receiving an increasing number of adverse event reports about medical devices that are used in the home.
CDRH wants to decrease the number of problems that occur in the home environment; but the issues are complex. To be successful, the government agencies involved in home care need to collaborate with relevant stakeholders:
- Manufacturers and Distributors
- Health care professionals
- Health care organizations
- Accrediting bodies (Private or governmental bodies that grant recognition that an institution has met certain standards or requirements)
- Human factors experts
This website will provide safety information and resources about medical products used in the home environment geared for a variety of audiences – consumers, patients, healthcare providers and manufacturers.
- Proposed Rule: Declaration of Labeling for Home-Use Medical Devices, October 17, 2016 Federal Register Publication
- Public Workshop - Medical Device Patient Labeling, September 29-30, 2015
- Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF Only)
- Medical Device Home Use Initiative - White Paper (PDF - 56KB)