The Center for U.S. Policy is asking the FDA to deem Bamboo Health's pharmaceutical software NarxCare as a misbranded product.
Bamboo describes NarxCare as a "clinical decision support and analytics solution" that "helps clinicians and care team members evaluate controlled substance data from government managed and regulated prescription drug monitoring programs to make more informed prescribing decisions," according to its website.
The organization filed the petition in late April with allegations of Bamboo violating federal law by not complying with FDA requirements for medical devices. The Center for U.S. Policy said NarxCare — which calculates patient-specific "risk scores" for opiates and other drugs — should not be deemed a device because of what the center considers an unclear algorithm.
Read the petition here.