FDA Loosens Regulations on Digital Pathology Devices During Outbreak

The FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories during the COVID-19 pandemic to expand their availability for pathology activities.

The agency said in an emergency final guidance that it will permit labs to make modifications to certain digital pathology devices to allow their use remotely for reviewing and reporting slides.

The FDA “recognizes that greater access to remote digital pathology devices may help facilitate the remote reviewing and reporting of pathology slides during this public health emergency,” the agency said.