FDA issued guidances on Remote Digital Pathology and Non-invasive Fetal and Maternal Monitoring devices
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic.
“This policy isintended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS.”
“FDA recognizes thatgreater access to remote digital pathology devices may help facilitate the remote reviewing and reporting of pathology slides during this public health emergency which, in turn, may help facilitate continuity of patient care and reduce healthcare personnel contact and risk of exposureto SARS-CoV-2.”
“Modified use of these devices may increase access to important prenatal data without the need for in-clinic visits andfacilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency.”
“Increased utilizationof non-invasive fetal and maternal monitoring devices may ease burdens on hospitals and other healthcare facilities and reducethe risk of exposure for patients and health care providers to SARS-CoV-2”
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
