Updated September 11, 2021
Links broke in the original post.
You can still read about the topic here:
FDA Home Use Devices Initiative Webpage
- - - original post below - - -
The FDAnews reports, "The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said."
New sets of instructions for patient, prescriber, and trainer will have ramifications for home care providers.
Learn more about the FDA Home Use Device Initiative:
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
You can still read about the topic here:
FDA Home Use Devices Initiative Webpage
- - - original post below - - -
The FDAnews reports, "The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said."
New sets of instructions for patient, prescriber, and trainer will have ramifications for home care providers.
Learn more about the FDA Home Use Device Initiative:
- FDA to Address Challenges of Using Complex Medical Devices in the Home
- FDA Medical Device Home Use Initiative (pdf)
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog