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www.fdanews.com/articles/152619-fda-finalizes-guidance-on-devices-intended-for-use-in-rare-diseases

FDA Finalizes Guidance on Devices Intended for Use in Rare Diseases

January 24, 2013
The FDA has announced the release of a new guidance document intended for both its staff and the medical device industry pertaining to the issuance of humanitarian use device HUD designations for devices intended to treat rare diseases or conditions.
Regulatory Focus