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FDA Draft Guidance: How To Claim Humanitarian Device Status

Firms must document that humanitarian devices target a rare disease or condition, or a small subset of a common disease or condition, the draft explains.

FDA issued draft guidance Dec. 13 to help manufacturers prepare requests for “humanitarian-use device” designation, a necessary first step in submitting pre-market applications for products intended for small populations of patients.

Humanitarian devices treat or diagnose a disease or condition that affects fewer than 4,000 patients a year. FDA also explains that humanitarian-use status may be requested for devices intended for...

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