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- Bcfa0f3ca349cdba7306f979ac9b686ba NCIT_P378 "NCI" @default.
- Bcfa0f3ca349cdba7306f979ac9b686ba type Axiom @default.
- Bcfa0f3ca349cdba7306f979ac9b686ba annotatedProperty IAO_0000115 @default.
- Bcfa0f3ca349cdba7306f979ac9b686ba annotatedSource NCIT_C80440 @default.
- Bcfa0f3ca349cdba7306f979ac9b686ba annotatedTarget "A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA." @default.