News Column

QMED -FDA Will Regulate the Message, Not the Medium

July 8, 2014



ENP Newswire - 08 July 2014

Release date- 04072014 - FDA has released a new Draft Guidance, 'Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,' that reflects the agency's evolving thinking on the question of what, exactly, constitutes a medical device that the agency must regulate.

In the Introduction, the agency says it 'recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.

'The FDA is issuing this draft guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.'

With the advent of mobile health devices, the agency has apparently decided that it must maintain its regulation of the message, but can leave the medium to the device makers. This will likely be seen as a wise move, lest the agency consume scarce resources in approving the never-ending parade of platform updates.

In the Draft Guidance, the agency differentiates between what it considers to be actual medical devices, and those that are merely medical device data systems. The Draft Guidance defines medical device data systems (MDDS) as 'hardware or software products that transfer, store, convert formats, and display medical device data' without modifying the data. An MDDS 'does not control the functions or parameters of any connected medical device' and is 'not intended to be used in connection with active patient monitoring.'

An MDDS, the agency says, is intended to 'provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices.' The uses specified are the electronic transfer or exchange of medical device data, the electronic storage and retrieval of medical device data, the electronic conversion of medical device data from one format to another, and the electronic display of medical device data.

The Draft Guidance then proceeds to give examples, such as a glucometer that must be regulated, and the mobile device (e.g., an iPhone) that merely reports the data and therefore doesn't need regulation.

Of striking significance is the rapid downgrading of the risk perceived by the agency. As recently as 2011, MDDS were considered Class III (high risk). Now FFA is basically saying that these devices pose such a low risk that it doesn't need to worry about them. What a difference a day (or 3 years) makes!


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Source: ENP Newswire


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