FDA finalizes guidance on medical device data systems

The Food and Drug Administration Friday issued final guidance on medical device data systems. The guidance confirms the agency’s intention not to enforce regulations for technologies that receive, transmit, store or display data from medical devices unless they involve active patient monitoring or require timely response. In addition, the agency updated its guidance for mobile medical apps to be consistent with the MDDS final guidance. The agency will discuss the new guidance, along with draft guidance documents released last month on low-risk products intended for general wellness and medical device accessories, at a Feb. 24 webinar for manufacturers and other interested stakeholders.