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- B4c037285658695363bfdc09860b58631 NCIT_P378 "FDA" @default.
- B4c037285658695363bfdc09860b58631 NCIT_P381 "eCTD" @default.
- B4c037285658695363bfdc09860b58631 type Axiom @default.
- B4c037285658695363bfdc09860b58631 annotatedProperty NCIT_P325 @default.
- B4c037285658695363bfdc09860b58631 annotatedSource NCIT_C82667 @default.
- B4c037285658695363bfdc09860b58631 annotatedTarget "Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration." @default.