FDA seeks to expand use of remote digital pathology devices amid pandemic
The US Food and Drug Administration (FDA) on Friday issued a temporary enforcement policy easing regulatory requirements for digital pathology devices to expand the availability of remote reviewing and reporting of pathology slides amid the coronavirus disease (COVID-19) pandemic.“Increased availability of these devices may help to facilitate continuity of patient care by preventing disruptions to critical pathology services rendered by clinical laboratories, hospitals, and other healthcare facilities, and by reducing healthcare personnel contact and risk of exposure to SARS-CoV-2,” FDA writes.
The policy applies to Class II digital pathology devices regulated under four product codes, OEO, PSY, QKQ and PZZ, which are normally limited to use in Clinical Laboratory Improvement Amendments-certified clinical laboratories and hospitals.
FDA notes that on 27 March, the Centers for Medicare & Medicaid Services said it would exercise enforcement discretion to allow pathologists to review pathology slides and images remotely under certain conditions during the pandemic.
Under FDA’s temporary policy, the agency says it does not intend to object to modifications to already cleared digital pathology devices to allow for remote use or the marketing of new remote digital pathology devices without submitting a 510(k), so long as the devices do not create an undue risk. FDA also says that companies modifying or marketing digital pathology devices under the policy do not need to comply with good manufacturing practice (GMP) or unique device identification (UDI) requirements, or special controls typically applied to such devices.
The policy also outlines labeling and performance requirements for companies to adhere to in order to modify or market devices in line with the policy.
FDA