Regulations.gov document
Ref 9 - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical…
Supporting & Related Material · FDA-2018-N-0236 · posted Oct 5, 2021
Key facts
| Document ID | FDA-2018-N-0236-0033 |
|---|---|
| Title | Ref 9 - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals De Novo Classifications and Humanitarian Device RE: Medical Device De Novo Classification Process |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2018-N-0236 |
| Posted | Oct 5, 2021 |
At a glance
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