FDA Proposes Non-Enforcement of Controls on Medical Device Data Systems
The Food and Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here). Under the policy, if adopted, FDA would not “enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices,” it said. Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).
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Medical device data systems are hardware or software products that transfer, store, convert formats, and display medical device data, says FDA. Examples include devices that collect output on carbon dioxide content from a patient’s ventilator for transfer to a central repository, store a patient’s historical blood pressure information, convert data from a pulse oximeter into another format for printing, or display previously stored electrocardiograms.
Medical device data systems are currently classified as low-risk Class I devices subject to the lowest level of device controls. FDA says the devices were originally classified as Class III (high-risk) devices, but were reclassified in 2011 after FDA determined they pose a low risk. FDA says further study of medical device data systems continues to show that they present a low risk, so it is proposing “a compliance policy whereby FDA would not intend to enforce compliance with the regulatory controls that apply to [medical device data systems] devices, medical image storage devices, and medical image communications devices.”
(Federal Register 06/25/14)