FDA Does Not Plan To Regulate Medical Device Data Systems


On Friday, FDA issued draft guidance saying that it considers medical device data systems to be safe and does not intend to regulate such tools, FierceHealthIT reports (Bowman, FierceHealthIT, 6/20).

The draft guidance marks a shift in FDA policy, as the agency as recently as January 2011 had said that medical device data systems are among the highest-risk technologies in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In a blog post accompanying the draft guidance, Bakul Patel, senior policy adviser for FDA's Center for Devices and Radiological Health, wrote that the change in policy comes in response to "additional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According to the draft guidance, medical device data systems do not aim to control or "alter the functions ...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As a result of FDA's draft guidance, medical device data systems -- such as software that collects data from a glucometer or a weight scale -- no longer will have to comply with FDA rules, Modern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 He added that the draft guidance is consistent with the health IT risk-based framework released in April by FDA, the Federal Communications Commission and the Office of the National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).

James Keuning
"This is authorized lawlessness, which does not seem to me to be the best approach." Anyone seen The Wire? Remember Hamsterdam? The title of this post says that FDA does not intend to regulate... however what is actually happening is that the FDA is announcing that they do not intend to enforce compliance with current regulations. And note: "this guidance (does) not establish legally enforceable responsibilities." I'm not predicting Hamsterdam of the medical device world, I'm just sayin' that "does not intend to enforce" is not a hall pass. 60 days to submit comments; interested parties might want to ask for a toothier statement.
William Hyman
This is the FDA's version of the long legendary grace interval on speed limits, i.e. its OK to go 10 mph over the limit, except when the cop thinks it isn't. I More generally "regulatory discretion" has meant "yes, you did it, but we are going to let you get away with it". If you hadn't done it, no discretion would be required. Now we have "yes, you are subject to the law, but we are going to let you get away with not complying with it". This is authorized lawlessness, which does not seem to me to be the best approach. Can you picture a teen caught doing something saying: " buy you dont obey the law at work, why do I have to?".

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