إرشادات إدارة الغذاء والدواء (FDA) حول التطبيقات الطبية للأجهزة المحمولة UCM263366
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Page Count: 45
- Preface
- Mobile Platform
- Mobile Application (Mobile App)
- Mobile Medical Application (Mobile Medical App)
- Regulated Medical Device
- Mobile Medical App Manufacturer
- Mobile medical apps: Subset of mobile apps that are the focus of FDA’s regulatory oversight
- Mobile Apps for which FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act)
- Examples of mobile apps that are NOT medical devices
- Examples of mobile apps for which FDA intends to exercise enforcement discretion
- Examples of mobile apps that are the focus of FDA’s regulatory oversight (mobile medical apps)
- Examples of current regulations
- Brief description of certain device regulatory requirements
- Frequently Asked Questions (FAQs)
- I have a mobile app not identified in this guidance. What is the best way to get additional information from the FDA about my product?
- Why does FDA recommend that manufacturers follow the Quality System (QS) regulation for those mobile apps that MAY be devices and could be mobile medical apps but for which FDA intends to exercise enforcement discretion?
- Is FDA’s QS regulation similar to software development practices I already use?
- What are some examples of parts of the QS regulation that are of particular importance to mobile medical apps and where can I find more information about them?
- Do all the mobile medical apps have to submit a premarket submission and receive FDA clearance or approval before marketing?
- Some FDA classifications state they are “510(k) exempt.” What does 510(k) exempt mean and how do I know if it applies to my product?
- If a 510(k) is required for my mobile medical app, what type of software documentation does FDA recommend I include in the submission?
- I am a medical device manufacturer and making my product labeling available electronically using a mobile app. Is my app considered a mobile medical app?
- Does an electronic method of collecting clinical investigations for example through a mobile app considered a mobile medical app, what requirements apply?
- I am a medical device manufacturer. Is an electronic method of collecting and storing quality systems information in my manufacturing process considered a medical device or a mobile medical app?
- Additional Resources