On February 15, 2011, the Food and Drug Administration (“FDA”) published a final rule reclassifying Medical Device Data Systems (“MDDS”) as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defined MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications, or display “medical device data.” FDA explicitly excluded electronic health record (“EHR”) and computerized physician order entry (“CPOE”) systems from the MDDS Final Rule. Because MDDS do not “provide new or unique algorithms or functions,” FDA concluded that general controls, such as the Quality System Regulations are sufficient to mitigate any risks associated with MDDS.

The final MDDS rule will become effective April 18, 2011. By May 18, 2011, all manufacturers of MDDS must register their establishments and list their MDDS products with FDA. No later than April 18, 2012, all manufacturers of MDDS must develop and implement procedures to ensure compliance with the QSRs and the Medical Device Reporting requirements. FDA does not intend to enforce design control requirements retroactively to any currently marketed device that is classified as “MDDS” under the final rule. However, FDA stated that it will enforce design control requirements for design changes made after the April 18, 2011 effective date to currently-marketed MDDS.

For more information, read our full alert.