# Medical Devices; Medical Device Data Systems
> **Food and Drug Administration** · Final rule. · Published 2011-02-15 · Effective 2011-04-18 · 76 FR 8637
## Document
- **Document number:** 2011-3321
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 8637
- **CFR reference:** 21 CFR 880
- **Publication date:** 2011-02-15
- **Effective date:** 2011-04-18
- **HHS docket:** Docket No. FDA-2008-N-0106
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/02/15/2011-3321/medical-devices-medical-device-data-systems)
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