- You might also like FDA GMP QSR cGMP Training - online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
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MDDS Rule - a webpage on FDA.gov
- - - the original post follows below - - -
The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.
Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].
Return Home: http://drughealth.blogspot.com/
You might also be interested in:
MDDS Rule - a webpage on FDA.gov
- - - the original post follows below - - -
The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.
Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].
Return Home: http://drughealth.blogspot.com/
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You might also like FDA GMP QSR cGMP Training - online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
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