Product Liability Update - FDA Issues New Draft Guidance on Medical Device Data Systems


by Daniel S. Wittenberg

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical image communications devices, due to the low risk they pose to patients. The guidance, titled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” is a clarifying follow-up to the January 2011 regulation that down-classified medical device data systems. In a blog released along with the publication, Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health, wrote that since 2011, “… FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.” Mr. Patel further expressed that “[t]oday, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.”

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