Download FDA Guidance - Mobile Medical Applications - Sept 25, 2013 PDF Free - Full Version
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About FDA Guidance - Mobile Medical Applications - Sept 25, 2013
This document provides guidance for industry and FDA staff on the regulation of mobile medical applications (mobile apps). It outlines three categories of mobile apps: 1) those that are not medical devices, 2) those for which FDA intends to exercise enforcement discretion, and 3) mobile medical apps, which are the focus of FDA regulation due to potential risks if they do not function as intended. The guidance aims to clarify FDA's regulatory approach and provide predictability for manufacturers of mobile medical apps.
Detailed Information
| Author: | ['Xiang Liu'] |
|---|---|
| Publication Year: | 2014 |
| Pages: | 43 |
| Language: | English |
| Format: | |
| Price: | FREE |
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