Medical Device Home Use Initiative

Home Use Devices Initiative | FDA

https://www.fda.gov/medical-devices/home-use-devices/home-use-devices-initiative

1) Issuing “Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use” to encourage manufacturers to take into consideration a...

Medical Device Home Use Initiative - Food and Drug …

https://www.fda.gov/media/78647/download

FDA is launching the Medical Device Home Use Initiative to improve the safety and safe use of medical devices in the home. Through this initiative, FDA will take proactive …

FDA Activities: Home Use Devices | FDA

https://www.fda.gov/medical-devices/home-use-devices/fda-activities-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 …

Unique Considerations in the Home | FDA

https://www.fda.gov/medical-devices/home-use-devices/unique-considerations-home

Specific Devices for Home Use | FDA

https://www.fda.gov/medical-devices/home-use-devices/specific-devices-home-use

This page provides important information about FDA-regulated medical products commonly used in the home including home use tests. Home Healthcare Medical Devices: A …

Frequently Asked Questions About Home Use Devices

https://www.fda.gov/medical-devices/home-use-devices/frequently-asked-questions-about-home-use-devices

Dispose of your medical device according to the manufacturer’s instructions. You may also wish to contact your pharmacist, nearest hospital, solid waste company, or state or local …

FDA's Role in Regulating Medical Devices | FDA

https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices

Home Use Devices Initiative; Unique Considerations in the Home; Specific Devices for Home Use; Frequently Asked Questions About Home Use Devices; FDA's Role in …

FDA Launches Initiative to Provide Oversight to Home Use …

https://codacorpusa.com/fda-launches-initiative-to-provide-oversight-to-home-use-medical-devices/

The Home Use Initiative also contains measures for enhanced post market surveillance through HomeNet, a subnetwork of the FDA’s Medical Device Surveillance Network, an …

Medical Devices in Home Use - Clinical Device Group

https://www.clinicaldevice.com/Whitepapers/13-09-12_Medical_Devices_in_the_Home.htm

The Home Use Device Initiative aims to: 1) establish guidelines for manufacturers of home use devices, 2) develop a home use device labeling repository, 3) partner with home …