As reported in Health Data Management, the FDA is proposing that Medical Device Data System (MDDS) software be reclassified from a Class III to a Class I medical device. A Class III medical device is the most stringent and expensive regulatory classification and must receive pre-market approval from the FDA. Class I classification is the least stringent classification.
The FDA report summary states:
SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression.
The entire report can be found as document ID fr08fe08P, Devices: General Hospital and Personal Use Devices.
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