The FDA released a draft guidance on the submission process for humanitarian use device designation for devices that diagnose or treat diseases and conditions effecting fewer than 4,000 Americans per year, according to a MassDevice report.
The program is run by the agency's Office of Orphan Products Development. The guidance explains how manufacturers should define a patient population for the device, demonstrate the device's efficacy for that group and how demonstrating efficacy varies whether the device treats or diagnoses a disease or condition.
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The program is run by the agency's Office of Orphan Products Development. The guidance explains how manufacturers should define a patient population for the device, demonstrate the device's efficacy for that group and how demonstrating efficacy varies whether the device treats or diagnoses a disease or condition.
Related Articles on the FDA:
Commentary: Free the FDA
FDA Approves Intuitive Surgical's Single-Site Instrumentation for Gallbladder Surgery
FDA Finds Problems in Johnson & Johnson Contract Drug Factory