FDA proposed reclassifying medical device data systems
Device Regulation Alert: Safety, Compliance and Reimbursement News, March 17, 2008
The FDA wants to reclassify medical device data systems (MDDS) from a Class III device requiring premarket approval to a Class I device subject to general controls, according to a Federal Register notice.
An MDDS is a computer-based or software-based medical device that performs one of more of these functions:
- Takes medical data from one device to a central location
- Stores medical data
- Displays data such as electrocardiograms
- Collects data from home systems such as glucose meters
The FDA also proposes to exempt an MDDS that will be used only by healthcare professionals and doesn't perform "irreversible data compression" from premarket notification requirements.
The FDA is accepting comments on the proposal until May 8.
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