FDA Finalizes Limited Regulatory Oversight of Certain Software Products

February 11, 2015

By Jennifer D. Newberger

On February 9, less than a year after issuing the draft, FDA issued a final guidance document confirming its exercise of enforcement discretion with respect to medical device data systems (MDDS), medical image storage devices, and medical image communications devices.  In line with the draft guidance, on which we blogged here, FDA has confirmed its intent not to enforce compliance with the regulatory controls previously applicable to the named devices.  This means manufacturers of those devices will not be required to register and list, or comply with the quality system regulation (QSR) or medical device and recall reporting.

Perhaps the most important takeaway from the guidance is that FDA has stated that it will also exercise enforcement discretion with respect to the named devices even if the device is intended for assessing the risk of cardiovascular disease or for use in diabetes management.  With the influx of apps and web services available to aid in diabetes management, FDA’s official position will be welcome news to many in the industry.

FDA also issued an updated version of its Mobile Medical Applications guidance, first released on September 25, 2013 (here), to incorporate the position outlined in the MDDS guidance.  For example, the September 25, 2013 mobile apps guidance indicated that an app that acted as an MDDS would be subject to registration and listing, QSRs, and medical device and recall reporting.  Since FDA has stated that it will not enforce regulatory compliance for MDDS products, the mobile apps guidance has been revised to reflect that position.

FDA has continued to indicate its intent to focus its efforts on higher risk technology products.  Hopefully, this trend will continue.

Categories: Medical Devices