New MDDS Final Rule Offers Class I Status For Off-The-Shelf Medical Devices

A new FDA final rule for Medical Device Data Systems (MDDS) went into effect this past month, with the intent of simplifying the regulations surrounding a significant portion of IT equipment and software used during the provision of health services. The key aspect of this new final rule is the reclassification of certain MDDS as Class I devices.

Until recently, Medical Device Data Systems – “off the shelf” hardware and software which were used to display, transfer, store or convert data – were considered Class III devices. This meant that the path to market for MDDS manufacturers included the need to seek premarket approval. By reclassifying these medicals devices as Class I, the need for premarket review is eliminated. Instead, manufacturers will only be required to satisfy the requirements expected of low-risk devices, including compliance with FDA Quality Systems regulations, reporting adverse events, and listing the MDDS products that they produce.

There are some exemptions to this reclassification, as the FDA does not consider systems which handle electronic or personal health records, computerized physician order entries, or word processing systems to be MDDS. Also falling outside the sphere of this definition are systems that monitor data that is critical to keeping a patient alive, such as blood pressure cuffs and glucose monitors.

Although MDCI (a full-service CRO) has covered what this new final rule means for medical device apps in a previous blog post, there is another interesting aspect of the new MDDS final rule which bears mentioning, and that concerns the FDA’s decision to specifically include hospitals and health centers under the heading of “manufacturers” within the document. Essentially, the FDA uses language which makes it clear that any modification to an existing off-the-shelf MDDS by hospital or any other health staff defines those organizations “manufacturers” for the purposes of the final rule. This is also true for any health organizations that develop their own in-house software or systems that perform MDDS functionality.

The regulatory change, which has been on the horizon for several years at the FDA (since 2008), marks a decisive split between IT systems which “add value” to medical data, and those which merely interact with that data and do not alter it in any way. From a common sense standpoint, MDCI feels that it makes sense for the FDA to view the latter as low-risk medical devices, as it will reduce the backlog of premarket applications as well as open up the field to wider competition from companies attracted by the reduced costs of selling these types of products. By May 16, 2011 manufacturers will be required to register and list all MDDS that they produce, and full compliance with the new regulation is mandatory as of April 16, 2012.

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republished and adapted with permission from MDCI

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