FDA: Draft Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations

Comments and suggestions regarding this draft document should be submitted within _90_ days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.