There is good news for certain sectors of the medical device industry. FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps). In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA announced the availability of two new guidance documents which are intended to put industry on notice of FDA's policy change. The guidance documents are currently available on FDA’s website:
Previously, MDDS and medical image storage and communication devices, and similar mobile medical apps, were regulated by FDA as Class 1, 510(k)-exempt devices. As such, they were subject to FDA's medical device labeling, medical device reporting, establishment registration, product listing and Quality System Regulation requirements, among others. The policy change greatly decreases the regulatory burden on these types of devices by not requiring manufacturers and other responsible parties for these types of devices to comply with these requirements.
The MDDS guidance provides that FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS, medical image storage devices and medical image communication devices. The September 25, 2013 version of the "Mobile Medical Applications" guidance has been updated to be consistent with the MDDS guidance. In relevant part, the updated version deletes the example of Mobile Apps that would be regulated as an MDDS and adds that it intends to use enforcement discretion for apps that are “intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 21 CFR 880.6310).” The guidance also provides an example of when a mobile app meets the definition of an MDDS and gives other examples of where FDA will use enforcement discretion.
Although this is good news for industry, FDA has strict definitions of what it considers an MDDS device, a medical Image storage system and a medical image communication system. Before taking advantage of the decreased regulatory burden in regulatory and business planning (e.g., commercializing new products, modifying treatment of existing products, etc.), firms need to truly make sure that FDA would view their device as falling into one of these categories. Wrongly relying on your device falling into one of these categories could translate into an FDA compliance action against your company.
For those firms which have a good basis for claiming their product falls into one of these categories, it is important to document why in a written regulatory rationale. In this way, if FDA or a third-party ever questions your conclusion, you can use the rationale to convince FDA or the party that you are correct or to at least demonstrate your "good faith" deliberations.