The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring.”

The core issue it raises, I believe, is one of data integrity. More on that later.

The new draft guidance cites the growing trend “that many medical devices be interoperable with other types of medical devices and with various types of health information technology,” the FDA wrote. And further, “Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.... Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices.”

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