Medical Devices; Medical Device Data Systems
Information
Type
Rule
Regulated products
Medical Devices
Published
February 15, 2011
Last updated
February 15, 2011
Description
Document number 2011-3321. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)