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The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.

The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.


The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.

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