FDA - Final MDDS Rule - Federal Register Full-Text

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MDDS Rule - a webpage on FDA.gov

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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)].

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FDA Issues MDDS Final Rule

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Updated March 11, 2021

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FDA finalizes regulation for certain software, hardware used with medical devices - Rule provides more predictable path to market.

The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Here's a thought-provoking article, Final MDDS rule deems hospitals medical device manufacturers. In this article, it mentions, "The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following: . . ."

As of this writing, the Medical Device Data Systems rule will be published in the Federal Register. Read the rule here: Medical Devices; Medical Device Data Systems - FDA Final Rule (PDF).

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