The Food and Drug Administration (FDA) issued a guidance designed to help expand the availability of devices for remote reviewing and reporting of scanned digital images or pathology slides.
The new policy will be in effect only for the duration of the COVID-19 public health emergency, the agency said.
To facilitate the use of these devices by pathologists remotely, the FDA said it would not object to the alteration or modification of FDA-cleared devices or the marketing of new pathology devices for remote use.
The type of devices included in the guidance are automated digital image manual interpretation microscopes, whole slide imaging systems, digital pathology image viewing and management software, and digital pathology displays.
The FDA’s guidance followed an earlier memorandum on the topic of remote viewing of pathology slides issued by the Centers for Medicare & Medicaid Services (CMS). In that memorandum, CMS said pathologists may review pathology slides remotely if the primary lab is certified to conduct testing in cytology; the temporary site, which can be a physician’s home, complies with applicable federal laws including HIPAA; and equipment and supplies are not kept at the temporary site permanently.
In general, FDA has not cleared digital pathology devices for home use, and as a result, these devices have been limited to use in clinical laboratories, hospitals and other healthcare settings that are CLIA-certified to perform nonwaived testing, the FDA said.
