FDA Finalizes Medical Device Data Systems Rule
This post was written by Katie Hurley and Areta Kupchyk.
The FDA has published a final rule reclassifying Medical Device Data Systems (MDDS) as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defines 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. The rule is effective April 18, 2011, and all manufacturers of MDDS must register their establishments and list their MDDS products with FDA by May 18, 2011. No later than April 18, 2012, all manufacturers of MDDS must develop and implement procedures to ensure compliance with Quality System Regulations and Medical Device Reporting requirements. For more information, see a Reed Smith alert analyzing the rule.
