MITA Comments Sway FDA to Update Solid State X-Ray Imaging Devices Guidance


The US Food & Drug Administration (FDA) has issued an updated Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, originally released in 1999. MITA’s SSXI Task Force, launched by the X-Ray section in March 2016, provided input that better matched the guidance document with current technology to the FDA. The revisions to Section VII, Clinical Consideration clarify that nonclinical information may be sufficient to support the substantial equivalence of a subject device to a predicate device for some SSXI modifications without the need to provide additional clinical data. If clinical information is considered necessary, the document outlines another option to the 30-pair image pair comparison in Section VII.B Qualified Expert Evaluation.

Click here to access the Guidance.