News On FDA Home Use Device Initiative

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:

• AAMI on FDA Launches Home Use Device Initiative
• FDA to Address Challenges of Using Complex Medical Devices in the Home
• FDA Medical Device Home Use Initiative (pdf)

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