FDA Seeking to Actively Regulate Computer/Software Products That Transmit, Store, or Display Medical Device Data

The Food and Drug Administration (FDA) is proposing to actively regulate a new class of computer- and software-based products that electronically collect, transfer, and store data from medical devices such as glucose meters and blood pressure devices. FDA is calling these products “Medical Device Data Systems” or “MDDS.” Such systems may be used, for example, to allow doctors to remotely monitor patients who require long-term care and potentially reduce the need for numerous hospital check-ups and doctor’s visits. If FDA’s proposal is finalized, these types of telehealth and other MDDS devices would be subject to Class I medical device regulation, requiring manufacturers of such products to ensure compliance with FDA regulations.

Currently, MDDS products are considered, by default, Class III medical devices, the highest level of FDA device regulation. However, FDA has not enforced the Class III requirements against MDDS manufacturers under a policy of enforcement discretion. In a February 8 proposed rule, FDA signaled its intent to down-classify MDDS devices to Class I, the lowest level of device regulation. FDA also stated that, once the rule is finalized, it intended to cease its practice of enforcement discretion for MDDS manufacturers.

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