Regulations.gov document
Ref 2 - Guidance for the Content of Premarket Submissions for Software Contained in…
Supporting & Related Material · FDA-2018-N-0236 · posted Oct 5, 2021
Key facts
| Document ID | FDA-2018-N-0236-0030 |
|---|---|
| Title | Ref 2 - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 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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