Document Type



Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence


Computer Sciences

Publication Details

Journal of Medical Device Regulation. 8(3)


On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In addition, the authors will be discussing the challenges medical device manufacturers face in the changing regulatory environment.



Science Foundation Ireland