Download Premarket Software Functions Guidance PDF Free - Full Version
Download Premarket Software Functions Guidance by ['Valentin C.'] in PDF format completely FREE. No registration required, no payment needed. Get instant access to this valuable resource on PDFdrive.to!
About Premarket Software Functions Guidance
This draft guidance provides recommendations on documentation sponsors should include in premarket submissions for FDA evaluation of device software functions. It identifies software information generally necessary for evaluating safety and effectiveness, including a software description, system architecture diagram, risk management file, requirements and design specifications, development and testing practices, and issue tracking. The guidance aims to help facilitate FDA's premarket review when finalized.
Detailed Information
| Author: | ['Valentin C.'] |
|---|---|
| Publication Year: | 2022 |
| Pages: | 39 |
| Language: | English |
| Format: | |
| Price: | FREE |
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