MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can skip the 510(k) process for premarket clearance.
The proposed change in regulation affects a wide range of devices, including wireless scales and glucose meters. The FDA defined "medical device data systems" as:
Hardware or software products that transfer, store, convert formats, and display medical device data. A MDDS does not modify the 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 proposal represents a dramatic about-face for the FDA, which prior to February 2011 classified MDDS among the highest-risk Class III medical devices, requiring that they undergo review through the most stringent premarket approval process. In February 2011 the agency downgraded MDDS to Class I.
"The Food and Drug Administration recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes," the agency said in its draft guidance. "The FDA is issuing this draft guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that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."
The proposal must undergo a period of public comment before the FDA issues its final decision.
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