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About Policy For Device Software Functions and Mobile Medical Applications Guidance For Industry and Food and Drug Administration Staff
This guidance document from the FDA summarizes their regulatory approach to device software functions and mobile medical applications. It defines key terms, clarifies the scope of software functions that are considered medical devices and subject to FDA oversight. It also provides examples of software functions that are not medical devices, those where the FDA intends to exercise enforcement discretion, and those that are the focus of regulatory oversight. The guidance aims to provide clarity and predictability for software manufacturers.
Detailed Information
| Author: | ['Entera Plenitud'] |
|---|---|
| Publication Year: | 2021 |
| Pages: | 45 |
| Language: | English |
| Format: | |
| Price: | FREE |
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