FDA Humanitarian Device Exemption
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory pathway
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:approvalType |
premarket approval exemption
|
| gptkbp:benefit |
increases access to devices for rare conditions
|
| gptkbp:compatibleWith |
demonstration of effectiveness
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
no comparable device available
probable benefit outweighs risk device treats or diagnoses a disease affecting fewer than 8,000 individuals per year in the U.S. |
| gptkbp:establishedBy |
Safe Medical Devices Act of 1990
|
| gptkbp:establishedIn |
1990
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Humanitarian Device Exemption
|
| gptkbp:limitation |
cannot be used for profit except in certain cases
limited to small patient populations |
| gptkbp:purpose |
facilitate approval of devices for rare diseases
|
| gptkbp:regulates |
21 CFR 814 Subpart H
|
| gptkbp:relatedTo |
gptkb:Orphan_Drug_Act
Humanitarian Use Device |
| gptkbp:requires |
Humanitarian Use Device (HUD) designation
evidence of safety |
| gptkbp:bfsParent |
gptkb:Argus_II_Retinal_Prosthesis_System
|
| gptkbp:bfsLayer |
7
|