Dear All
The U.S. Food and Drug Administration (FDA) issued its proposed "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications". The agency is seeking comments and suggestions regarding this aforesaid draft document, which described its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smart phones and other mobile computing devices.
The draft guidance defines a small subset of mobile medical apps that:
- is used as an accessory to a regulated medical device; or,
- transforms a commercial off-the-shelf computing platform into a regulated medical device.
For more details please refer here.
Regards
S.Subramaniam
The U.S. Food and Drug Administration (FDA) issued its proposed "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications". The agency is seeking comments and suggestions regarding this aforesaid draft document, which described its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smart phones and other mobile computing devices.
The draft guidance defines a small subset of mobile medical apps that:
- is used as an accessory to a regulated medical device; or,
- transforms a commercial off-the-shelf computing platform into a regulated medical device.
For more details please refer here.
Regards
S.Subramaniam
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