Software developers who were hoping that the Food and Drug Administration’s Center for Devices and Radiological Health might issue draft guidance on clinical decision support (CDS) software have once again been disappointed.
According to the FDA, its Center for Devices and Radiological Health (CDRH) is considering developing a variety of guidance in fiscal year 2017, including its so-called “A-List” documents, those that the agency intends to publish between Oct. 1, 2016 and Sept. 30, 2017. However, draft CDS guidance is not among CDRH’s priorities going into next year.
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