Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday.
CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, the recommendations apply to premarket approval applications, humanitarian device exemption applications, 510(k)s, investigational device exemption applications and de novo classification requests.
“Medical imaging is used routinely in hospitals and clinics to assist with the diagnosis and management of patients with a variety of diseases and conditions, by providing visual representations of the internal structures of the body,” CDRH says. “Most medical images are acquired with the intention of qualitative interpretation by a trained physician to identify the presence or absence of a structure or feature.”
Medical devices that include quantitative imaging functions, however, are intended to extract additional information in the form of numerical values compared to clinicians’ qualitative interpretations of medical images. Quantitative imaging values span across several different imaging modalities, intended uses, levels of automation as well as the complexities of the algorithms used for the imaging processing.
Yet the values have also been known to be subject to systematic errors and random variation, which can in turn impact clinical decision-making. CDRH aims to limit these risks with the draft guidance by encouraging greater consistency in the information and technical data provided in support of quantitative imaging functions…