The draft guidance marks a shift in FDA policy, as the agency as recently as January 2011 had said that medical device data systems are among the highest-risk technologies in health care.
In a blog post accompanying the draft guidance, Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health, wrote that the change in policy comes in response to “additional experience” the agency gained through its efforts to ease regulatory burdens on the devices (Tahir, Modern Healthcare, 6/20).
According to the draft guidance, medical device data systems do not aim to control or “alter the functions … of any connected medical devices,” but rather are intended to:
- Facilitate electronic transfer or exchange of medical device data;
- Store and retrieve medical device information, such as blood pressure data;
- Convert medical device data from one format to another; and
- Display medical device information (FierceHealthIT, 6/20).
As a result of FDA’s draft guidance, medical device data systems — such as software that collects data from a glucometer or a weight scale — no longer will have to comply with FDA rules, Modern Healthcare reports (Modern Healthcare, 6/20).
Patel said that the policy change will allow medical device data system developers to focus on boosting interoperability with other medical devices. He added that the draft guidance is consistent with the health IT risk-based framework released in April by FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT (FierceHealthIT, 6/20).
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